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Apalutamide is an anti-cancer agent used for the management of prostate cancer. A new stability indicating RP-HPLC method (Gradient mode) has been developed for the estimation of Apalutamide and its related substances using Waters Alliance system (Model no. 2996 and 2695) with Inertsil ODS-3 (250 x 4.6 mm, 5μm) column (PDA detector) was used for the present study. A mixture of Ammonium phosphate buffer solution and Acetonitrile (30: 70, v/v) was used as the mobile phase for the chromatographic study (Flow rate: 1.0 mL/min; Detection wavelength: 243 nm). Stress degradation studies were performed and the method was validated as per ICH guidelines. [ABSTRACT FROM AUTHOR]

Tavaborole, a topical antifungal agent containing Boron is used for the treatment of onychomycosis, an infection of the nail and nail bed caused by Trichophyton rubrum or Trichophyton mentagrophytes infection. Tavaborole is chemically known as 5 - Fluoro -1,3 - dihydro -2,1-benzoxaborol -1-ol. It acts by inhibiting Leucyl-tRNA synthetase an essential fungal enzyme required for protein synthesis. AB SCIEX Instruments LC-ESI-MS/MS (Model no. 5068379-Y) QTRAP Enabled Triple Quad 5500+ with Agilent Zorbox C18 (150 mm x 4.6 mm x 3 µm) column and PDA detector was employed for the present study. The total run time was 10 mins and the detection wavelength was 254 nm. A mixture of 5 mM Ammonium formate: Methanol (30: 70) was used as mobile phase on isocratic mode with 1 ml/min as flow rate. Tavaborole has shown linearity over the concentration range 0.5-100 μg/ml and the proposed method was validated as per ICH guidelines. The proposed method is found to be simple, precise, accurate and suitable for the quantification of the marketed formulations of Tavaborole. Stress degradation studies were performed and the method is found to be selective and specific. [ABSTRACT FROM AUTHOR]

Abstract The present research aims to establish new stability indicating RP-UPLC method for concurrently estimating Pregabalin and Etoricoxib in blended powder and their combined tablet formulation. The effective separation of Pregabalin and Etoricoxib achieved with HSS column C18 (150 × 2.1 mm, 1.8 µm), 0.1% orthophosphoric acid: acetonitrile in 65:35 v/v) at a flow rate of 0.3 mL/min, and isocratic elution at 228 nm. The elution of PRB and ETB was noticed at 1.56 and 2.01 min, with good resolution and system suitability with the developed approach. PRB and ETB have shown linear responses from 18.75 to 112.5 µg/mL and 15 to 90 µg/mL, respectively. The range of the % RSD for intraday and inter-day precision was 0.33 to 0.81. The LOD and LOQ of Pregabalin and Etoricoxib were computed to be 0.07 µg/mL, 0.21 µg/mL, and 0.01 µg/mL, 0.04 µg/mL, respectively, by standard deviation method. The validation method was carried out using ICH standards. The stability- indicating the feature of the method was confirmed by the forced degradation studies where degradants generated by stress testing were clearly distinguished from the peaks of analytes. The shorter elution period and superior sensitivity of both analytes with this method are appropriate for regular analysis of Pregabalin and Etoricoxib. Graphical Abstract

The present research aims to establish new stability indicating RP-UPLC method for concurrently estimating Pregabalin and Etoricoxib in blended powder and their combined tablet formulation. The effective separation of Pregabalin and Etoricoxib achieved with HSS column C18 (150 × 2.1 mm, 1.8 µm), 0.1% orthophosphoric acid: acetonitrile in 65:35 v/v) at a flow rate of 0.3 mL/min, and isocratic elution at 228 nm. The elution of PRB and ETB was noticed at 1.56 and 2.01 min, with good resolution and system suitability with the developed approach. PRB and ETB have shown linear responses from 18.75 to 112.5 µg/mL and 15 to 90 µg/mL, respectively. The range of the % RSD for intraday and inter-day precision was 0.33 to 0.81. The LOD and LOQ of Pregabalin and Etoricoxib were computed to be 0.07 µg/mL, 0.21 µg/mL, and 0.01 µg/mL, 0.04 µg/mL, respectively, by standard deviation method. The validation method was carried out using ICH standards. The stability- indicating the feature of the method was confirmed by the forced degradation studies where degradants generated by stress testing were clearly distinguished from the peaks of analytes. The shorter elution period and superior sensitivity of both analytes with this method are appropriate for regular analysis of Pregabalin and Etoricoxib.Article Highlights: A new RP-UPLC method for analysis of Pregabalin and Etoricoxib in powder and tablet form. Simple mobile phase and economical column for separation of Pregabalin and Etoricoxib. Shorter retention time with isocratic elution and effective resolution. Greater sensitivity regarding LOD and LOQ. Stability indicating method through the forced degradation studies. [ABSTRACT FROM AUTHOR]

Aim: Vildagliptin and Dapagliflozin in fixed-dose combination is used for treatment of Type II Diabetes Mellitus. The key objective of the current research work is to develop a new stability-indicating UHPLC method for the simultaneous estimation of Vildagliptin and Dapagliflozin in tablet dosage form as no such method is available. Materials and Methods: A successful separation was achieved by using Agilent column C18 (4.6×100 mm) and mobile phase of Methanol: 0.1% Orthophosphoric acid (78:22) at a flow rate of 1.0 mL and detection wavelength of 234 nm. The forced degradation study was performed at extreme forced conditions such as hydrolysis with acid and base, peroxide oxidation and photolytic degradation, following ICH guidelines. Results: The retention time for Vildagliptin and Dapagliflozin was 2.3 and 4.7 min respectively. The suggested approach yields linear responses for Vildagliptin and Dapagliflozin in the concentration of the 50-250 µg/mL and 5-25 µg/mL, respectively. Limit of Detection (LOD) and Limit of Quantification (LOQ) were found to be 1.04 µg/mL and 3.15 µg/mL for Vildagliptin and 0.24 µg/mL and 0.73 µg/mL for Dapagliflozin, respectively. In the exposed conditions, the drugs did not exhibit any significant degradation. Conclusion: The UHPLC approach that was recommended proved to be highly sensitive, accurate, precise, robust and stability indicating. The method can be successfully adopted for the routine analysis for the simultaneous estimation of the Vildagliptin and Dapagliflozin in bulk and pharmaceutical dosage form. [ABSTRACT FROM AUTHOR]

Background and Aim: The current study attempted to invent and evaluate an easy and sensitive Stability indicating UV spectrophotometric method for simultaneous determination of Glimepiride and Pioglitazone HCl. Material and Methods: To provide a simple, sensitive, robust, precise, and accurate Stability indicating UV-Spectrophotometric method for the simultaneous estimate of Glimepiride and Pioglitazone HCl, as well as to develop a combined tablet dosage formulation of Glimepiride and Pioglitazone HCl. The best conditions for drug analysis were found using Methanol as the solvent. Results and Discussion: Glimepiride and Pioglitazone Hydrochloride had maximum absorption wavelengths of 227.6nm and 266.8nm, respectively. Glimepiride and Pioglitazone Hydrochloride demonstrated linear responses between concentration ranges of 2-12g/ml and 5-30g/ml, respectively. It was discovered that the linear regression coefficient was 0.999. According to ICH criteria, the method was validated for sensitivity, specificity, range and linearity, precision, and ruggedness, all validation results were found to be within acceptable limits. Glimepiride and pioglitazone HCl were exposed to forced degradation under ICH guidelines. The resulting samples were used for deterioration experiments utilizing the established procedure. Conclusion: As a result, it may be argued that the procedure was novel, straightforward, precise, specific, and selective for the simultaneous estimation of Glimepiride and Pioglitazone HCl in bulk Drugs. [ABSTRACT FROM AUTHOR]

For the simultaneous determination of anti-hypertensive drugs Hydrochlorothiazide (HCTZ) in bulk and tablet dosage forms, a simple, specific, accurate, and precise stability-indicating UV-Vis Nanodrop 2000c method was developed and validated. The maximum absorption of Hydrochlorothiazide was revealed at 271 nm using methanol as a solvent. The validation results showed good linearity (R2 = 0.9997) within the concentration range of 10-50 µg/mL. The RSD revealed an acceptable value (less than 0.6 percent) in the precision study at three levels. 1.01 and 3.3g µg/mL were found to represent the LOD and LOQ, respectively. Locally and commercial tablets are Available Drug Products. Accuracy at three levels showed good recovery, more than 99% percent. The proposed method was used to analyse the stability of local and commercial tablets. The stability of their pharmaceuticals was investigated under acidic, oxidative, thermal, alkaline, and photolytic conditions in this research. In accordance with the guidelines set by the International Council for Harmonisation (ICH), the method was effectively validated. Subsequently, the validated method was employed to analyze commercially available pharmaceutical dosage forms. [ABSTRACT FROM AUTHOR]

A rapid, stability indicating reverse phase liquid chromatographic method was developed for the determination of purity of Felodipine in active pharmaceutical substance form in the presence of its impurity and its degradation products. To develop the method which is also compatible to liquid chromatographic mass spectroscopic technique. The developed method is also used to determine the assay of Felodipine in bulk drug form. The drug is subjected to various stress conditions like acidic, basic, oxidation, UV light and thermal conditions. Considerable degradation was observed during base hydrolysis. Two degradation products were identified. The Waters Acquity UPLC BEH C18, 2.1 × 100 mm, 1.7 µm Column was used to achieve chromatographic separation. The gradient conditions, diluent and injection volume were optimized to achieve the acceptable resolution between impurities and its degradation products from Felodipine and to get good peak shapes. The masses were determined for main compound and its identified degradation products. Further, the characterization studies for main compound and its degradation products were performed using LCMSMS Q-TOF. [ABSTRACT FROM AUTHOR]

The analytical community prioritizes adopting green techniques due to concerns over the environmental impact of chemical research. This study employs an integrated experimental strategy, combining the concept of design of experiment (DOE) and green analytical chemistry (GAC), to establish a robust, green RP-HPLC approach for the simultaneous estimation Cilnidipine (CIL) and Metoprolol succinate (MET). For method optimization, a central composite design (CCD) was implemented. Separation utilized Inertsil ODS 3 column (250 mm x 4.6 mm, 5 μm), with gradient mobile phase (ethanol: 17.65% at 0 min, 75.5% at 3 min) and phosphate buffer, flowing at 1 ml/ min. Detection wavelength at 230 nm. Column temperature (35±1°C), and injection volume 5 μL. Retention times: MET (4.672 min), CIL (7.457 min). The linearity was established over the range of 7-13 μg/ml for CIL and 35-65 μg/ml for MET. The values obtained for LOD and LOQ are 0.819 and 2.482 μg/ml (CIL) respectively, 3.875 and 11.743 μg/ml (MET). As per ICH Q14, the technique has been validated. Finally the green nature was examined by GAPI, AES and AGREE. Method found to be ecofriendly, simple and robust for simultaneous CIL and MET estimation in pharmaceutical formulations, easily adaptable for routine analysis. [ABSTRACT FROM AUTHOR]

Abstract Two rapid, precise, and sensitive stability-indicating high performance chromatographic methods for the measurement of Teriflunomide in its degradation products’ existence were developed. These were RP-HPLC and HPTLC using UV detector. HPLC separation was accomplished utilizing Thermo BDS hypercil C18 column (250 × 4.6 mm, 5 μm) and acetonitrile: 0.03 M potassium dihydrogen phosphate: triethylamine (50:50:0.1%, by volume) as mobile phase at flow rate of 1mL/min. The separated peaks were detected at 250.0 nm. The densitometric approach was conducted utilizing HPTLC 60 F254 silica gel plates, and a developing system of benzene: ethanol: acetic acid (7.5:1:0.25, by volume) and detection was done at 250.0 nm. The developed approaches were evaluated regarding the International Conference on Harmonization (ICH) instructions. The calibration curves of both techniques were constructed with linearity ranges of (5-100) µg/mL and (2–10) µg /band, for HPLC and densitometric determination, consecutively. Teriflunomide was exposed to base and acid hydrolysis, oxidation using H2O2 and finally, thermal degradation as stated in ICH guidelines. The degradation product structures’ elucidation was achieved through LC-MS.

Two rapid, precise, and sensitive stability-indicating high performance chromatographic methods for the measurement of Teriflunomide in its degradation products' existence were developed. These were RP-HPLC and HPTLC using UV detector. HPLC separation was accomplished utilizing Thermo BDS hypercil C18 column (250 × 4.6 mm, 5 μm) and acetonitrile: 0.03 M potassium dihydrogen phosphate: triethylamine (50:50:0.1%, by volume) as mobile phase at flow rate of 1mL/min. The separated peaks were detected at 250.0 nm. The densitometric approach was conducted utilizing HPTLC 60 F254 silica gel plates, and a developing system of benzene: ethanol: acetic acid (7.5:1:0.25, by volume) and detection was done at 250.0 nm. The developed approaches were evaluated regarding the International Conference on Harmonization (ICH) instructions. The calibration curves of both techniques were constructed with linearity ranges of (5-100) µg/mL and (2–10) µg /band, for HPLC and densitometric determination, consecutively. Teriflunomide was exposed to base and acid hydrolysis, oxidation using H2O2 and finally, thermal degradation as stated in ICH guidelines. The degradation product structures' elucidation was achieved through LC-MS. [ABSTRACT FROM AUTHOR]

Curcumin (CUR) is a phytochemical widely used in food industries, cosmetics, and in the treatment of various ailments. It is a polyphenol derived from turmeric and is often considered the golden spice. CUR has a low solubility of less than 1 µg/ml and poor oral bioavailability which can be improved by co-amorphization with naringin (NRG). Analytical method to simultaneously quantify CUR and NRG is not reported in literature. This study aimed to develop a stability-indicating reverse phase HPLC method in gradient mode to simultaneously quantify CUR and NRG in co-amorphous system. The co-amorphous system of CUR and NRG in molar ratios 1:1 and 1:2 was prepared by quench cooling technique. The separation was attained on a Genesis C18, (4.6 mm × 150 mm, 4 µm) column with the mobile phase comprising of methanol and a 0.1% acetate buffer pH 3.8 at a single wavelength, 289 nm. CUR and NRG eluted at 5.1 and 11.1 min, respectively. For both the molecules, the linearity range was 0.125–16 µg/ml with LOD and LOQ of 0.063 and 0.125 µg/ml. The method developed was validated as per International Conference on Harmonization (ICH) guidelines for linearity, accuracy, precision, and robustness. The method was used to estimate CUR and NRG content in co-amorphous mixture and for in vitro evaluation. [ABSTRACT FROM AUTHOR]

Background: Teneligliptin is a new drug recently approved by FDA for treatment of type 2 Diabetes Mellitus (DMT 2). Very few methods have been reported for analysing its degradation products and their impact on human health. Materials and Methods: A precise, specific, and sensitive gradient UHPLC technique was developed and validated to analyze Teneligliptin using an Agilent C18 column (4.6x100 mm ID) with 2.5 µm particle size. The method employs a flow rate 0.9 mL/min and detects the teneligliptin at a wavelength 241 nm. This method comprises a mobile phase consists a mixture of Methanol with 0.1% TEA (60:40%v/v), along with a 20 µL injection volume for duration of 20 min. Results: Linearity was found in the range of 2-10 µg/mL having a correlation coefficient of 0.999. The retention time for Teneligliptin was found to be 2.382. Furthermore, the precision and robustness of the method were validated with a remarkable RSD (Relative Standard Deviation) below 2%. Conclusion: The method's stability under various stress conditions was confirmed through forced degradation studies conducted on both bulk substances and pharmaceutical dosage forms. Validation of the method followed the guidelines outlined by the ICH for assessing the validation parameters like specificity, linearity, accuracy, precision, robustness, LOQ and LOD. [ABSTRACT FROM AUTHOR]

The primary goal of the proposed study is to establish and validate a low‐cost, sensitive, reliable, and trouble‐free RP‐UPLC process with improved performance for the direct estimation of Lixisenatide in pure powder and fixed‐dose tablet form. The proposed method is optimized by implementing quality by design studies. The method is optimized using quadratic model of central composite design (CCD) of randomized response surface study. Successful separation of Lixisenatide is obtained by the use of Phenyl‐XBD (1.7 µm, 2.1 mm × 100 mm) column and a mobile phase of acetonitrile: 0.1% w/v OPA (60:40) with 0.5 mL min−1 flow rate. The separated Lixisenatide and its degradants are explorated with PDA detector which has the ability to provide comprehensive spectral information, rapid data acquisition, quantitative analysis, and peak purity analysis of all compounds simultaneously. The RT of Lixisenatide is found to be 1.34 min. The lowest concentration of Lixisenatide's limit of detection and limit of quantification makes guarantees regarding the method's sensitivity. For the provided range of linear concentrations (1.25–7.5 µg mL−1), the regression coefficient is found to be 0.999. The computed average percentage recoveries of Lixisenatide in spiked solutions ranged from 98.9% to 101.2%. The % degradation of Lixisenatide in the presence of a variety of forced conditions confirms the existing method's stability. Lixisenatide is significantly photo sensitive when compared to other stressful conditions such as acid, base hydrolysis, and oxidation. The proposed UPLC approach separates Lixisenatide with high sensitivity, a short retention time, and an affordable solvent system. [ABSTRACT FROM AUTHOR]

A simple, Accurate, precise method was developed for the estimation of the Amantadine in bulk and pharmaceutical dosage form. Chromatogram was run through ACQUITY UPLC BEH C18 Column, 1.7 µm, 2.1 mm X 50 mm. Mobile phase containing 0.1% AmmoniumFormate: Methanol taken in the ratio 73.6 (%v/v) and 26.3 was pumped through column at a flow rate of 0.28 ml/min. Temperature was maintained at 29.21°C. Optimized wavelength selected was ACQUITY TUV ChA 219 nm. Retention time of Amantadine was found to be 1.814 min. %RSD of the Amantadine was found to be 0.4%. %Recovery was obtained as 99.94% for Amantadine. LOD, LOQ values obtained from regression equations of Amantadine were 0.05, 0.15. Regression equation of Amantadine is y = 52995x + 2524.1. with regression coefficient value is found to be 0.99. Retention times were decreased and that run time was decreased, so the method developed was simple and economical that can be adopted in regular Quality control test in Industries. [ABSTRACT FROM AUTHOR]

For the simultaneous determination of anti-hypertensive drugs Hydrochlorothiazide (HCTZ) in bulk and tablet dosage forms, a simple, specific, accurate, and precise stability-indicating UV-Vis Nanodrop 2000c method was developed and validated. The maximum absorption of Hydrochlorothiazide was revealed at 271 nm using methanol as a solvent. The validation results showed good linearity (R2 = 0.9997) within the concentration range of 10-50µg/mL. The RSD revealed an acceptable value (less than 0.6 percent) in the precision study at three levels. 1.01 and 3.3g µg/mL were found to represent the LOD and LOQ, respectively. Locally and commercial tablets are Available Drug Products. Accuracy at three levels showed good recovery, more than 99% percent. The proposed method was used to analyse the stability of local and commercial tablets. The stability of their pharmaceuticals was investigated under acidic, oxidative, thermal, alkaline, and photolytic conditions in this research. In accordance with the guidelines set by the International Council for Harmonisation (ICH), the method was effectively validated. Subsequently, the validated method was employed to analyze commercially available pharmaceutical dosage forms.

This work effectively developed and validated a stability-indicating RP-HPLC technique for precisely measuring dexlansoprazole in bulk samples. An Acetonitrile and 0.5 mmol Ammonium Acetate (pH 4.5) gradient mobile phase, a 1 ml/min flow rate, and detection at 283 nm were all part of the method's unique chromatographic conditions. A Kromasil C18 column was also used. Dexlansoprazole had a 5.14-minute retention period, and the technique showed a linear range of 5-30 mg/ml with a strong correlation value of 0.997. The technique showed high sensitivity with a limit of detection (LOD) of 1.2 mg/ml and a limit of quantification (LOQ) of 3.64 mg/ml. The accuracy of the approach was shown by the percentage recovery of dexlansoprazole, which varied from 98.6% to 102%. The International Council for Harmonisation (ICH) gave standards for validating the created approach, which were followed. It covered several variables: linearity, LOD, LOQ, accuracy, precision, robustness, and solution stability. The technique demonstrated stability and the capacity to successfully separate the degradation products from the analyte peaks, establishing its validity as a stability-indicating technique. LC-MS/MS spectra were also used to establish the degradants' structures. The quantitative measurement of dexlansoprazole in bulk form may be accomplished effectively using this established RP-HPLC technique. It is a useful instrument for quality control and stability evaluation of dexlansoprazole in pharmaceutical formulations because of its accuracy, precision, and stability-indicating capabilities. [ABSTRACT FROM AUTHOR]

There is no stability-indicating specific related substances high-performance liquid chromatography (HPLC) method for anagliptin active pharmaceutical ingredients in the presence of its degradation products. Hence, there is a necessity to have a specific stability-indicating HPLC method for the quantification of anagliptin-related substances in the presence of its forced degradation products. The aim of the research work is to develop an innovative simple, accurate, precise, and selective HPLC method with the lesser use of organic solvents, for the quantification of anagliptin-related substances in the presence of its forced degradation products. The chromatographic separation was achieved on a YMC Pro C18 reversed-phase HPLC column (250 mm × 4.6 mm, 5 μ) with a runtime of 50 min. Mobile phase A and mobile phase B were chlorate buffer with pH 3.2 and acetonitrile respectively. The HPLC column oven temperature was set at 28°C and the photodiode array detector was set at 205 nm. The proposed test procedure has shown excellent linearity within the concentration range 0.081–6.296 μg/mL with correlation coefficient (r) about 0.9998. The limit of detection of anagliptin and related substances was observed within the range 0.052–0.106) μg/mL and the limit of quantification was observed within the range 0.156–0.317 μg/mL. The developed test procedure was successfully utilized for the quantification of related substances of anagliptin bulk drug without any interference with the degradation compounds. Hence, the test procedure can be utilized successfully in pharmaceutical organizations for the separation and quantification of anagliptin-related substances. [ABSTRACT FROM AUTHOR]

Solriamfetol is a dopamine and norepinephrine reuptake inhibitor used to treat excessive daytime sleep in patients with narcolepsy. The prime intention of this study was to develop a simple, accurate, precise and robust RP-HPLC method for the estimation of solriamfetol in pure and marketed dosage forms. The chromatographic analysis was performed on a Waters symmetry C18 column (150 × 4.6 mm, 5 μ) using a mobile phase containing a mixture of 0.1% formic acid: acetonitrile at 30:70, v/v. A flow rate of 1 mL/min was applied and detected at a wavelength of 257 nm. Solriamfetol eluted at 2.4 min over a run time of 5 min. The method showed linearity in the range of 12.5 to 75 μg/mL with a correlation coefficient of 0.9998. The sample solution was exposed to various stress conditions and shows degradation in the range of 3.4% to 27.2%. The solriamfetol peak was well resolved from the degradation peaks observed in stress degradation, which proves the specificity of the method. The developed method was found to be linear, accurate, precise, sensitive, simple and economical with a short analysis time. Thus, this method can be utilized for regular study in quality control labs for the quantification of solriamfetol in bulk and pharmaceutical dosage forms. [ABSTRACT FROM AUTHOR]

A stability-indicating RP-HPLC method for the development of Telmisartan (TTN) and Azelnidipine (ADN) is analyzed in tablet dosage form. The quantification of TTN and ADN combination is done by Supel cosil C18 column (250 mm, 4.6 mm, & 5 µm). Isocratic mobile phase had mobile phase consists of 0.10M Na2SO4(pH 3.6) and acetonitrile (pH 3.6) as 55:45v/v. For this analysis flow rate is measured as 1.00 mL/minute. Wavelength is identified as 258nm to examine TTN and ADN. Stability for both these drugs under distinctive environments were performed. Injected volume is 10 µL. Run time is 8 minute. Retention time is 2.8 and 3.7 respectively. The responses were linear in the concentrate range as 37.4-110.3 for TTN and 2.24-10.51 µg/mL for ADN respectively. Percent comparative standard deviance to precision is 0.193% for TTN, 0.195% for ADN. Percent assay to accuracy for both these drugs are 98.76% and 99.04% respectively. LOD values for TTN and ADN were 0.020 µg/mL and 0.065 µg/mL and LOQ values for TTN and ADN were 0.009 µg/mL and 0.031 µg/mL. Robustness studies revealed that this method is robust by percent comparative standard deviance. This stability-indicating RP-HPLC procedure to both TTN, ADN analysis is more simple, highly sensitive, more precise, highly specific and robust, making it appropriate to the assessment of TTN and ADN in formulation. [ABSTRACT FROM AUTHOR]

This study was motivated by the fact that certain food poisonings and harmful microorganisms in ethanol and water determine roselle (Hibiscus sabdariffa), rosemary (Rosmarinus officinalis), clove (Syzygium aromaticum), and thyme (Thymus vulgaris). is to exhibit the capacity to eliminate Least inhibitory focuses (MICs) of different plant extricates against Gram-positive microorganisms (Bacillus cereus, Staphylococcus aureus), Gram-negative microscopic organisms (Escherichia coli, Enteritidis, Vibrio parahaemolyticus, Pseudomonas aeruginosa) and parasites (Candida albicans) and antibacterial impacts were explored. It is dissolved and measured using the agar well dispersion technique. The concentrate showed antimicrobial efficacy against the microorganisms and yeast used in the tests. Both pHint reduction and cell layer hyperpolarization indicated that the plant extract had a profound effect on the membranes of Gram-positive and Gram-negative microorganisms. Overall, plant extracts have significant potential as unique regular food additives due to their antibacterial properties. [ABSTRACT FROM AUTHOR]

Rivaroxaban is an anticoagulant used to prevent thromboembolism after hip or knee joint replacement surgery. The purpose of study was the development of an efficient, simple and economic reverse phase HPLC-PDA method for Rivaroxaban determination in pharmaceutical dosage forms and blood plasma of human beings. The separation was carried out at room temperature by using Thermo Scientific ODS Hypersil C18 (250×4.6mm, 5µm) and mobile phase 70:30 (%v/v) mixture of ACN / H2O, 1.2 ml/min flow rate, detection on 253nm wavelength by PDA detector with run time of about 7 mins. The retention time observed was about 3 mins. The validation was performed on the proposed method in accordance with ICH guidelines and found that the method is linear within the range of 100-400µg/mL with the correlation coefficient 0.9996. The method was also precise, accurate, robust and rugged, and showed specificity in all applied stress conditions i.e. photolytic (200-800nm, 3h) thermal (70°C, 2h), oxidative (3% H2O2, 70°C, 1h), acidic (0.1 N, 70°C, 1h), and basic (0.1 N, 60°C, 1h). This method was applied successfully for the Rivaroxaban quantitative determination in pharmaceutical dosage and human blood plasma [ABSTRACT FROM AUTHOR]

In this study, an accurate, simple, economical and precise Reversed-Phase High Pressure Liquid Chromatography (RP-HPLC) method was developed for the simultaneous estimation of Ozenoxacin and Benzoic Acid in a pharmaceutical cream formulation, according to the International Conference on Harmonisation (ICH) guidelines. Chromatographic separation was achieved by gradient elution, on RP-HPLC Instrument, equipped with column C8 (150 mm × 4.6 mm, 5 μm particle size) using Ultra Violet (UV) detector at 235 nm wavelength, by using Mobile Phase A: triethylamine, trifloroacetic acid and water (1:1:1000) and Mobile Phase B: methanol and Diluent: water, acetonitrile and triethylamine (500:500:1), at flow rate 0.8 mL min−1; injection volume of 20 μL; column oven temperature 45 °C and sample temperature: 25 °C; Run time: 15 min. All the validation parameters were within the acceptance criteria, as per ICH requirements, for Ozenoxacin and Benzoic acid. Consequently, this method has found to be validated, simple, rapid and successfully applicable, to the simultaneous estimation of Ozenoxacin and Benzoic acid by RP-HPLC, for routine analytical testing in quality control, with a run time of 15 min and for future research studies. Forced degradation of Ozenoxacin cream 1% w/w formulation was performed and found that validated method has stability indicating potential that needs to be further studied. [ABSTRACT FROM AUTHOR]

A new fast stability-indication high performance liquid chromatography method was developed and validated for the determination of amlodipine besylate and its organic impurities in drug substance. The separation of amlodipine and its seven impurities was achieved on a core shell C18 column, 100 mm × 4.6 mm; 2.6 μm, within 15 min. The mobile phase comprised of 0.4% ammonium hydroxide in water and methanol delivered in a gradient mode; the method detection wavelength is 237 nm. The selected column is stable at high pH and provided a good peak shape for basic compounds. Amlodipine besylate was subject to acid, base, oxidative, thermal, and photolytic stress conditions. The degradation products were well resolved from the amlodipine peak and its impurities. Major degradants were analyzed by liquid chromatography coupled with single-quadrupole mass detector. Amlodipine peak was shown to be free of co-elution by mass spectral analysis in all stress conditions. The method was validated in terms of specificity, linearity, accuracy, precision, and robustness. The developed method could be applied for routine quality control analysis of amlodipine besylate drug substance.

Uterine Leiomyomata (commonly known as Fibroids in the uterus) are non-cancerous tumors, most commonly found in women at the premenopausal stage. They are estimated to be found at 33-77% during reproductive age and 70-80% during menopause. The current frontline treatments were ineffective and alternative pharmacological treatments were proposed. Thus, this study aimed at a therapeutic combination of Relugolix, Norethindrone acetate, and Estradiol is proposed. A precise, specific, simple, and selective stability indicating Ultra Performance Liquid Chromatography method for simultaneous determination of the combination has been developed and validated. The chromatographic separation was done by using an isocratic mobile phase of 50:50 v/v acetonitrile and buffer on a phenyl column (100 x 2.1 mm, 1.7 m) with 0.5 ml flow rate/minute, and 272 nm wavelength. The ability of the method to indicate stability was demonstrated by subjecting the Active Pharmaceutical Ingredients to various stressors using appropriate validatory international standard methods. The current study found that the system acceptability (SA), reproducibility (R), detection limits (DL), quantitation limits (QL), linearity (L), accuracy (A), precision (P), and specificity (S) were all within acceptable limits. [ABSTRACT FROM AUTHOR]

A nanodrop spectrophotometric method was developed and validated for determination of Valsartan (VAL) in both bulk and tablet dosage form. Using methanol as a solvent, valsartan's maximum absorption was observed at 243 nm. The developed method was found to be linear (R2 = 0.9999) within the concentration range of 10-50 µg/mL. The precision study gives RSD less than 1%. The LOD and LOQ values were 0.34 and 1.14 g/mL, respectively. The accuracy study revealed that Valsartan commercial products had a remarkable recovery rate of more than 98%. The current method was successfully applied for valsartan stability indication study in Arbiten, Lastavin, Tabuvan, Extra, and Diostar products commonly found in pharmacies in Iraq's Kurdistan area. The stability-indicating study was investigated under acidic, basic, oxidative, photolytic, and thermal conditions. The results of all products showed that VAL is unstable in acidic, alkaline, and oxidative conditions under heating at 60°C up to 3 hrs. While under photolytic and thermal conditions, the degradation percentage was more than 15% indicating to the instability of VAL in all products tablets in accordance to ICH International Conference on Harmonization guideline of drugs. [ABSTRACT FROM AUTHOR]

Eco-friendly liquid chromatographic methods for measuring ergotamine (EGT) are scant in the published database. Accordingly, the goal of the current study was to develop a high-performance thin-layer chromatography (HPTLC) method for fluorescence detection of EGT in commercially available tablets. This approach was based on the application of ethyl alcohol–water (80:20 v/v) as the eco-friendly eluent mixture. The fluorescence detection of EGT was carried out at 322 nm. The greenness score of the present approach was evaluated by "Analytical GREENness (AGREE)" technology. The present approach for measuring EGT in the 25–1000 ng band−1 range was linear. The present assay for fluorescence detection of EGT was validated successfully by ICH guidelines for various parameters. The method was found to be rapid, sensitive, eco-friendly, and stability-indicating. The computed AGREE index for the current strategy was 0.84, displaying outstanding greenness features. The present methodology successfully separated the EGT degradation products under forced-degradation circumstances, exhibiting its stability-indicating qualities and selectivity. An amount of 99.33% of EGT was found in commercial formulations, indicating the validity of the current method for pharmaceutical analysis of EGT in commercial products. The results showed that EGT in commercial products might be regularly measured by the existing method. [ABSTRACT FROM AUTHOR]

Background: Tigecycline (TGC) is a recently developed antibiotic to battle resistant bacteria. The procedures outlined in the literature for analyzing TGC involve chemical solvents that could be hazardous. Therefore, this study aimed to create a sustainable and stable HPLC technique for quantifying Tigecycline in lyophilized powder. The powerful chemometric tool, experimental design (ED), will be applied to analyze the variables' interaction and impact on the selected analytical target profiles. Response surface methodology provides a tutorial on using the central composite design with three levels of variables and quadratic programming to optimize the design space of the developed method. Methods: The New HPLC method consisted of an aqueous buffer and ethanol as a green mobile phase run on a reversed-phase symmetry C18 column. A full resolution between the Tigecycline and its degradation product peaks was achieved in a short analytical runtime. Results: Further, the specificity, accuracy, precision, robustness and stability indicating power of the proposed approach were verified through stress degrading testing. Conclusions: Finally, the analytical eco-scale and the green Analytical Procedure Index (GAPI) were utilized to determine how environmentally friendly the recommended method was compared to other published approaches.

An efficient, rapid, sensitive, validated stability-indicating ultraviolet spectrophotometric method was developed for flurbiprofen in eye drops. Methanol was employed as the solvent in this proposed process, and detection was carried out at a wavelength of 248 nm. The validation parameters linearity, limit of detection and limit of quantitation, accuracy, precision and specificity were all the subject of experiments according to International Council on Harmonisation guidelines. The stability of flurbiprofen was examined under acidic, alkaline, thermal, and photolytic conditions. The kinetics in the concentration range of 2-10 ug/ml were defined as linear with a correlation value of 0.992. The percentage of relative standard deviation for both intra-day and inter-day accuracy was under less than 2 % and 99.6 %-100.4 % of the drug was retrieved from the study. The system was able to identify variations related to stress conditions although the stress condition of degradation products hadn't been determined. The proposed approach can be employed as a stability indicating method for flurbiprofen screening in conventional pharmaceutical analysis of eye drops with a significant level of linearity, accuracy and precision. The method was found to be both affordable and convenient. This method can therefore be used to study flurbiprofen stress degradation behaviour in small industries without access to sophisticated equipment. [ABSTRACT FROM AUTHOR]

L-Methionine (Met) is an essential alpha-amino acid playing a key role in several metabolic pathways. Rare inherited metabolic diseases such as mutations affecting the MARS1 gene encoding methionine tRNA synthetase (MetRS) can cause severe lung and liver disease before the age of two years. Oral Met therapy has been shown to restore MetRS activity and improve clinical health in children. As a sulfur-containing compound, Met has a strongly unpleasant odor and taste. The objective of this study was to develop an optimized pediatric pharmaceutical formulation of Met powder, to be reconstituted with water, to obtain a stable oral suspension. Organoleptic characteristics and physicochemical stability of the powdered Met formulation and suspension were evaluated at three storage temperatures. Met quantification was assessed by a stability-indicating chromatographic method as well as microbial stability. The use of a specific fruit flavor (e.g., strawberry) with sweeteners (e.g., sucralose) was considered acceptable. No drug loss, pH changes, microbiological growth, or visual changes were observed at 23 ± 2 °C and 4 ± 2 °C with the powder formulation for 92 days, and the reconstituted suspension for at least 45 days. The developed formulation facilitates the preparation, administration, the dose adjustment and palatability of Met treatment in children. [ABSTRACT FROM AUTHOR]

Background: Tigecycline (TGC) is a recently developed antibiotic to battle resistant bacteria. The procedures outlined in the literature for analyzing TGC involve chemical solvents that could be hazardous. Therefore, this study aimed to create a sustainable and stable HPLC technique for quantifying Tigecycline in lyophilized powder. The powerful chemometric tool, experimental design (ED), will be applied to analyze the variables' interaction and impact on the selected analytical target profiles. Response surface methodology provides a tutorial on using the central composite design with three levels of variables and quadratic programming to optimize the design space of the developed method. Methods: The New HPLC method consisted of an aqueous buffer and ethanol as a green mobile phase run on a reversed-phase symmetry C18 column. A full resolution between the Tigecycline and its degradation product peaks was achieved in a short analytical runtime. Results: Further, the specificity, accuracy, precision, robustness and stability indicating power of the proposed approach were verified through stress degrading testing. Conclusions: Finally, the analytical eco-scale and the green Analytical Procedure Index (GAPI) were utilized to determine how environmentally friendly the recommended method was compared to other published approaches.

Background: Tigecycline (TGC) is a recently developed antibiotic to battle resistant bacteria. The procedures outlined in the literature for analyzing TGC involve chemical solvents that could be hazardous. Therefore, this study aimed to create a sustainable and stable HPLC technique for quantifying Tigecycline in lyophilized powder. The powerful chemometric tool, experimental design (ED), will be applied to analyze the variables' interaction and impact on the selected analytical target profiles. Response surface methodology provides a tutorial on using the central composite design with three levels of variables and quadratic programming to optimize the design space of the developed method. Methods: The New HPLC method consisted of an aqueous buffer and ethanol as a green mobile phase run on a reversed-phase symmetry C18 column. A full resolution between the Tigecycline and its degradation product peaks was achieved in a short analytical runtime. Results: Further, the specificity, accuracy, precision, robustness and stability indicating power of the proposed approach were verified through stress degrading testing. Conclusions: Finally, the analytical eco-scale and the green Analytical Procedure Index (GAPI) were utilized to determine how environmentally friendly the recommended method was compared to other published approaches.