A Validated Stability Indicating RP-UPLC Method for Atrovastain Calcium

Abstract

The present paper describes stability indicating reverse phase Ultra performance liquid chromatographic (RPLC) assay method for Atrovastatin Calcium in bulk drugs. The developed method is also applicable for the related substance de- termination and degradation products generated from forced decomposition studies. The drug substance was subjected to stress conditions of acid hydrolysis, base hydrolysis, oxidation, photolysis and thermal degradation. The degradation of Atrovastatin was observed under acid hydrolysis, base hydrolysis and peroxide hydrolysis. The drug was found to be stable to other stress conditions attempted. Successful separation of the drug from synthetic impurities and degradation product formed under stress conditions was achieved on a C18 column using buffer 0.02 M phosphoric acid and aceto- nitrile. The developed UPLC method was validated with respect to linearity, accuracy, precision, specificity and ro- bustness. The developed UPLC method to determine the related substances and assay determination of Atrovastatin can be used to evaluate the quality of regular production samples. It can be also used to test the stability sample of Atrovastatin Calcium