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Daclatasvir dihydrochloride (DTDH) is a direct-acting antiviral agent used against the hepatitis C Virus. Different analytical methods were reported for the determination of DTDH in pharmaceutical dosage form, including spectrophotometry, high-performance liquid chromatography (HPLC), and stability- indicating HPLC method but to date, no HPTLC method has been reported. A novel, simple, sensitive, selective, precise, and accurate stability-indicating high-performance thin-layer chromatographic (HPTLC) method has been developed for the quantification of Daclatasvir dihydrochloride (DTDH) in pharmaceutical formulation. Chromatography separation was carried out on pre-coated silica gel G60 F254 HPTLC plates using chloroform: methanol (9:1, v/v) as the mobile phase. Scanning and densitometric analysis were done at 316 nm. The band of DTDH were obtain at RF= 0.48±0.02. The calibration curve was plotted in the concentration range of 400– 900 ng/band and the method was found linear with r = 0.995. The LOD and LOQ were found to be 95 ng/band and 313.5 ng/band respectively. The percentage recovery was found to be 97.31-101.81 %. The developed was able to separate peaks of all the degradation products formed in ICH-prescribed stress conditions with a significant difference in their RF values. The developed method was validated according to ICH guidelines and results were found to be within acceptance criteria. The developed stability-indicating method successfully evaluated the DTDH in pharmaceutical tablet dosage form and assay results showed good recovery when statistically compared with the reversed-phase high-performance liquid chromatography (RP-HPLC) method. [ABSTRACT FROM AUTHOR]

Introduction: Lornoxicam is a selective cyclooxygenase-1 and 2 inhibitor that exhibit anti inflammatory, analgesic and anti pyretic activities. It is used in the management of osteoarthritis, rheumatoid arthritis, postoperative pain and primary dysmenorrhoea. Aim: The present work describes a simple, precise and accurate HPTLC method for its estimation as bulk and in tablet dosage form. Methods: The chromatographic separation was carried out on precoated silica gel 60 GF254 aluminium plates using mixture of Tetrahydrofuran: Methanol:Ethyl acetate:Ammonia (2:1.5:5.5:0.6 v/v/v/v) as mobile phase and densitometric evaluation of spots was carried out at 377 nm using CAMAG TLC Scanner-3 with win CATS 1.4.1 version software. The experimental factors like band width of spot, chamber saturation time, slit width, solvent front migration etc. were critically studied and optimum conditions were developed. Results: The drug was satisfactorily resolved with Rf value 0.34 ± 0.01. The accuracy and reliability of the proposed method was determined by evaluating various validation parameters like linearity (100-1000 ng/band), precision (intra-day RSD 0.05-0.10 %, inter-day RSD 0.04-0.13%), accuracy (98.26-100.60%) and specificity according to ICH guidelines. The drug was also subjected to acid, alkali, oxidation, thermal and photochemical degradation studies and the method was found to be effective in separating the drugs from their degradation products. Conclusion: The proposed method is simple, accurate, precise and may be used as a cost-effective quality control tool for routine analysis of Lornoxicam as bulk drug and in tablet formulation. [ABSTRACT FROM AUTHOR]

A simple, precise and sensitive high performance thin layer chromatographic (HPTLC) method has been developed and validated for drug of choice Lumefantrine in treatment of malaria (P. falciparum). Silica gel 60 F254 HPTLC precoated plates were used for quantitative analytical purpose. Methanol water 9.5 + 0.5 (v/v) was used as the solvent system. Densitometric scanning was carried out with deuterium lamp set at detection wavelength of 266 nm. The response to lumefantrine concentration was linear in the concentration range of 1.25-12.50 µg/ml. The suitability of the method developed and validated was in accordance with the requirements of the ICH guidelines (Q2B). Thus the validated method can be further applied to quantitative analysis of lumefantrine in commercial pharmaceutical dosage form. The proposed method is simple, sensitive, precise and accurate, confi rming its pharmaceutical application in routine quality control analysis. [ABSTRACT FROM AUTHOR]

Duloxetine hydrochloride is a potent dual reuptake inhibitor of serotonin and norepinephrine used to treat major depressive disorders. The present work describes a simple, precise and accurate HPTLC method for its estimation as bulk and in tablet dosage form. The chromatographic separation was carried out on precoated silica gel 60 F254 aluminium plates using mixture of chloroform:methanol (8:1 v/v) as mobile phase and densitometric evaluation of spots was carried out at 235 nm using Camag TLC Scanner-3 with win CAT 1.3.4 version software. The experimental parameters like band size of the spot applied, chamber saturation time, solvent front migration, slit width etc. were critically studied and optimum conditions were evolved. The drug was satisfactorily resolved with Rf value 0.11±0.01. The accuracy and reliability of the proposed method was ascertained by evaluating various validation parameters like linearity (40-200 ng/spot), precision (intra-day RSD 0.46-0.75%, inter-day RSD 0.46- 1.59%), accuracy (98.72±0.20) and specificity according to ICH guidelines. The proposed method can analyse ten or more formulation units simultaneously on a single plate and provides a faster and cost-effective quality control tool for routine analysis of duloxetine hydrochloride as bulk drug and in tablet formulation. [ABSTRACT FROM AUTHOR]