作者: Anuradha K K Gajjar , Vishal D D Shah
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摘要: A simple, precise and rapid stability-indicating reversed-phase high performance liquid chromatographic (RP-HPLC) method has been developed subsequently validated for the simultaneous estimation of Rosuvastatin (RSV) Ezetimibe (EZE) from their combination drug product. The proposed is based on separation two drugs in reverse phase mode using Hypersil C 18 150 x 4.6 mm, 5µ column maintained at a temperature 40°C. optimum mobile consisted 0.05 M phosphate buffer (pH 2.5)-Methanol (45+55, v/v), flow rate 1.0 mL min -1 UV detection was set 242 nm. Rosuvastatin, product were exposed to thermal, photolytic, hydrolytic oxidative stress conditions stressed samples analyzed by method. There no interfering peaks excipients, impurities or degradation products due variable specific RSV EZE presence products. according ICH guidelines. It found be accurate reproducible. Linearity obtained concentration range 5-80 m g both with correlation coefficients 0.99999 0.99994 respectively. % Mean recovery triplicate each level 98% 102% RSD less than 2.0%. can successfully applied quality control bulk manufacturing pharmaceutical dosage forms.