Method Development and Validation for Simultaneous Estimation of Atorvastatin and Ezetimibe in Pharmaceutical Dosage Form by HPLC

Abstract

A new HPLC method was developed and validated for the determination of Atorvastatin and Ezetimibe in tablet dosage form. The chromatographic separation was achieved on a Inspire C₁₈(4.6 x 250mm, 5mm)  with a mobile phase combination of phosphate buffer, methanol and Acetonitrile (40:10:50) at a flow rate  of 1.2 ml/min, and the detection was carried out  by using UV detector at 233 nm. The total run time was 8minutes.The retention time of phosphate buffer, methanol and Acetonitrile were found to be 2.237 min. and 3.164 min. respectively. The performance of the method was validated according to the present ICH guidelines.