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Objective: Vinorelbine (VNRB) is a chemotherapeutic drug used to treat non-small cell lung cancer and breast cancer. Literature survey reveals that there are no reverse-phase high-performance liquid chromatography (RP-HPLC) methods reported for the estimation of VNRB in spiked human plasma. Hence, the present work aimed to develop a simple and efficient RP-HPLC method for the estimation of VNRB in human plasma.Methods: Specimen preparation for the measurement of VNRB was performed through liquid-liquid extraction using methanol as extracting solvent and reconstructed with mobile phase. Paclitaxel (PCTX) was used as internal standard. HPLC method was optimized and validated as per the US FDA bioanalytical guidelines. VNRB and internal standard were separated on Kromasil® C18 (250×4.6 mm; id 5 μ) using acetate buffer (pH=5.9) and methanol in the ratio of 85:15 (v/v) at 1 ml/min flow rate. Eluted compounds were recorded using UV detector at 235 nm.Results: The retention time of PCTX and internal standard was found to be 4.3 and 9.0 min, respectively. The analytical measuring ranges were found to be 5–750 ng/ml (r2>0.9998). The method was found to be simple, accurate, precise, and stable and there is no interference of plasma matric components.Conclusion: The described HPLC method allows for the measurement of total and free PCTX in both plasma and cord blood and can utilize for the estimation of drug in pharmacokinetic studies.

Decitabine is an anti-cancer chemotherapy drug. This article describes method development and method validation of related substances of Decitabine (a- decitabine, a-isomer, methyl 4-chlorobenzoate, s-isomer, O-Acetyl and unknown impurities) in decitabine drug substance and finished dosage forms by using a high Performance liquid chromatography. In this high performance liquid chromatography, the resolution was achieved on Inertsil ODS 3V, 250×4.6 mm, 5µm column with a gradient elution at a flow rate of 1.2 mL/min using a mobile phase A as Ammonium acetate buffer solution and mobile phase B as water: acetonitrile (10:90% v/v) at wavelength 254 nm by an UV detector. The method was validated in the concentration range of 0.7 ppm to 7.1 ppm, 1.2 ppm to 11.0 ppm, 1.2 ppm to 10.9 ppm, 1.2 ppm to 11.0 ppm, 1.2 ppm to 10.9 ppm and 0.8 ppm to 7.7 ppm for related substances of a- decitabine, a-isomer, methyl 4-chlorobenzoate, s-isomer, O-Acetyl and Decitabine respectively. The obtained recovery was in between 90.0 % to 110.0 % and the % RSD was not more than 10.0. The HPLC method is suitable, specific, linear, accurate, precise, stability indicating and robust which may be useful for the routine and stability analysis for determination of related substances in Decitabine drug substance and finished dosages.

A novel high speed, high resolution Reverse phase-UPLC method was developed for the quantification of related substances in Febuxostat drug substance. The separation of drug from the possible impurities was achieved on a Halo C18 column. The innovative approach of using stationary phase with sub 2 μ particles provides a comprehensive combination of selectivity and speed. 10 mM mono basic potassium phosphate buffer at pH 2.7 and acetonitrile mixture was selected as mobile phase. Flow rate and detection were kept at 0.8 mL/min and 320 nm respectively. The developed UPLC method was subjected to validation parameters. System precision, accuracy, specificity, limit of detection, limit of quantification and linearity were established as per the guidelines recommended by ICH. Stability indicating nature of the method was also performed by exposing the sample under various conditions like acid, base, peroxide and photo stability exposures. Total analysis run time 7.0 minutes indicates the speed and cost saving initiation of the developed method. Using the method one can carry out the quantitative estimation of related substances in Febuxostat drug substance, further the same method can be adopted for determination of drug substance assay also.

Development and Comparative Assessment of Hydrocolloid Based Against Wax Based Gastro Retentive Bilayered Floating Tablet Designs of Atorvastatin Calcium Using Qbd Approach Atorvastatin calcium is one of the most widely prescribed lipid lowering drug and due to its acidic degradation properties the bioavailability reported is only 12-14% when administered orally. The gastro retentive floating tablets of Atorvastatin calcium had shown enhanced bioavailability compared to conventional immediate release dosage forms. The study presented here was focused on comparing the physicochemical properties of two different bilayered controlled release gastro retentive buoyant formulation designs of Atorvastatin calcium tablets. The buoyancy layer for first formulation was swelling hydrocolloid based (HPMC) against the second formulation design which was non swellable wax (HCO) based. The drug release characteristics, kinetic models, buoyancy characteristics and stability were compared between the two formulation designs. Apart the DoE (22 factorial design) studies were carried out to understand the impact and range of release controlling agents in drug layer against the dissolution profile in pH 4.5 acetate buffer. The buoyancy properties were observed to be consistent and stable in case of HPMC based buoyancy system, where as the wax based formulation design had shown tendencies for layer seperation at higher agitation speeds.

New High-performance liquid chromatographic bio-analytical method has been developed and validated for the simultaneous analysis of Trifluridine (TFD) and Tipiracil (TPC) in human plasma. The combination of TFD and TPC are used in the treatment of unresectable advanced or recurrent colorectal cancer. The method was developed with UV detector (at 260 nm wave length), Intersil ODSC 18 column (250 mm × 4.6 mm×5μ), at flow rate of 1.0mL/min. The mobile phase consisted of 15% NaClO4 buffer (PH 4.5 v/v), 85% Methanol. The retention times of TFD and TPC are 3.4 min and 7.4 min respectively. The method was developed and validated in terms of selectivity, precision, linearity, accuracy, LOQ, LOD and stability study. The proposed method can be applicable for pharmacokinetic studies using HPLC or LC-MS.