Development and validation of stability indicating high performance liquid chromatography method for determination of Atorvastatin calcium in the presence of its degradation products

The aim of this study was to optimize chromatographic method for the analysis of atorvastatin calcium and its degradation products using an experimental design approach. The purpose of a screening design is to identify the factors that have significant effects on the chromatographic responses and for this purpose we applies 2³ factorial design. The present study describes simple, accurate, precise and cost effective HPLC method for estimation atorvastatin calcium, the mobile phase used consists of acetonitrile: orthophosphoric acid 0.1%( 66:34 v/v), detection wavelength 246nm. A linear response was observed in the range of 6.4 µg/ml-9.6 µg/ml with correlation coefficient of 0.999, this method can be used as stability indicating method.

Author(s): Elsadig H. Rudwan, Amna B. W. E. Mohammed Hussien and Ahmed E. M. Saeed

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