Development and validation of stability indicating RP-HPLC method for the estimation of azilsartan in Bulk

Abstract

Angiotensin-receptor blockers are often considered adequately efficacious in reducing blood pressure. By accepting the current regulatory requirements for an analytical method development, a reversed phase high performance liquid chromatographic method for routine analysis of Azilsartan has been developed. The optimized method was achieved using unisol C-18 (3μm, 4.6×150mm) coloumn with mobile phase consisting of mixture acetonitrile and methonal (90:10v/v) with a flow rate of 0.8ml/min at 249nm. The Linear concentration range is 2-10μg/ml. The detection and quantitation limit was found to be 0.45μg/ml. And the detection limit was found to be 0.149μg/ml. There are no interfering peaks under performed degradation conditions. The optimized method was validated according to ICH guidelines.