Simultaneous assessment of atorvastatin-ezetimibe combination in tablets by an ion-pair rp-hplc

Abstract

The purpose of this work was to develop and validate a new ion-pair reversed phase high performance liquid chromatographic method on a standard C18-type stationary phase with UV detection, for the analysis of the two antihyperlipidemic agents as a combination in tablets atorvastatin-ezetimibe. The mobile phase consisted of a 35% of cetyltrimethylammonium bromide (cetrimide) 10−3 M as the ion-pairing agent and 65% acetonitrile. The pH value of the mobile phase was adjusted if necessarily by ammonia solution at 10. The flow rate was 1.5 mL/min and the separation was performed at 40°. The method validation was based on linearity, accuracy, precision and specificity. This method exhibited good linearity and accuracy with mean recovery values between 95–105%, precision with relative standard deviations of the calculated concentrations less than 2% and specificity in the presence of excipients. These results indicates that the proposed method is applicable for the separation and determination of atorvastatin-ezetimibe combination in tablets and could be a relevant method to utilize in quality control laboratories.