DEVELOPMENT AND VALIDATION OF UPLC METHOD FOR THE SIMULTANEOUS DETERMINATION OF ATORVASTATIN AND EZETIMIBE IN PHARMACEUTICAL FORMULATION

Abstract

A simple, rapid and accurate UPLC method was developed and validated for estimation of atorvastatin and ezetimibe in combined dosage forms. With the objective of reducing analysis time and maintaining good efficiency in the area of fast chromatographic separations the UPLC has proven to be one of the most promising developments in the area of fast chromatographic separations. In this work a isocratic reverse phase chromatographic method was developed using UPLC for the estimation of atorvastatin and ezetimibe in pharmaceutical formulations. The chromatographic separation of atorvastatin and ezetimibe was achieved as waters acquity BEH C18,50*2.1mm,1.7um column within a short runtime of 8min by using pioglitazone as IS. The method was validated according to the regulatory guidelines with respect to precision, accuracy and linearity