QUALITY BY DESIGN (QbD) BASED DEVELOPMENT OF A STABILITY INDICATING RP-HPLC METHOD FOR ESTIMATION OF COBICISTAT IN BULK

摘要

By considering the current regulatory requirement for an analytical method development, a reversed phase high performance liquid chromatographic method for routine analysis of cobicistat has been developed using analytical Quality by design approach. The optimized method was achieved using unisol C-18 (3?μm, 4.6 ×150 mm) column with mobile phase consisting of mixture of water and methanol (70:?30?v/v) with a flow rate of 1ml/min at 240 nm. The optimized method was then validated according to the ICH guidelines. The developed method was found linear over the concentration range of 10-80 μg/ml and the detection and quantitation limit was found to be 0.39μg/ml and 1.2μg/ml. There are no interfering peaks under performed degradation conditions. Therefore, a sensitive, robust, accurate and stability indicating method was developed with high degree of practical utility.