UV, HPLC and HPTLC methods were developed and validated for the quantitative determination of Pirfenidone, a novel antifibrotic agent used in idiopathic pulmonary fibrosis. Chromatography was carried out by isocratic technique on reversed phase Eclipse XDB-C 18 column (150 x 4.6 mm, 5µm) with mobile phase consisting of phosphate buff: acetonitrile (pH 3.5) 72:28 v/v at flow rate 1mL/min. TLC was carried out by stationary phase precoated Silica Gel 60 F 254 TLC Plate using mobile phase Toluene: Methanol, 8:2 v/v. The UV spectrophotometric determination was performed at 311nm using solvent methanol. The proposed methods were validated according to ICH Q2-(R1) guidelines. The linearity range for Pirfenidone was 5-70 µg/mL for HPLC, 800-1600 ng/spot for HPTLC and 10-60 µg/mL for UV method. These methods were accurate and precise with recoveries in the range of 98.2-102.32 and relative standard deviation < 2%. The developed methods were successfully applied for determination of Pirfenidone in tablets.
The study describes a validated stability indicating reverse-phase HPLC method for the estimation of tolperisone in bulk and in tablet formulation. The proposed RP-HPLC method utilizes a Hypersil C18 column (250 × 4.6 mm, 5 μm), optimum mobile phase consisted of methanol: acetonitrile: water (containing triethylamine 1% V/V) in the ratio of (85:10:5 V/V/V), effluent flow rate was kept at 1.0 mL/min and UV detection wavelength 250 nm. Tolperisone was exposed to various hydrolytic, thermal, photolytic and oxidative stress conditions, and the stressed samples were analysed by proposed method. The drug showed degradation under alkali and neutral hydrolysis and oxidative stress conditions. The degradation products were well resolved from the drug and demonstrated that the method is specific stability indicating for assay of tolperisone in presence of degradation products. The developed method was validated for linearity, accuracy, precision, robustness, ruggedness and specificity.
The study describes a validated stability indicating reverse- phase HPLC method for the simultaneous estimation of pantoprazole and cinitapride in capsule formulation. The proposed RP-HPLC method utilizes an Eclipse XDB C18 Column (150 × 4.6 mm i.d., 5μm), optimum mobile phase consisting of 10 mM phosphate buffer: acetonitrile: THF in the ratio of 64:36:0.5 V/V (pH 3.5) V/V, effluent flow rate 1 mL/min and UV detection wavelength of 266 nm. The selected chromatographic conditions were found to effectively separate pantoprazole and cinitapride with retention time of 7.17 min and 3.56 min, respectively. Linearity for pantoprazole and cinitapride was found in the range of 2-30 μg/mL and 0.15- 2.28 μg/mL, respectively. The developed method was statistically validated for the linearity, accuracy, precision, robustness, ruggedness and specificity. The proposed method was found to be simple, accurate, precise, economical and specific. Therefore, it can be used for simultaneous analysis of these drugs in capsule formulation.
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