Pharmaceutica Analytica Acta

Abstract

Simultaneous Estimation of Atorvastatin, Ezetimibe and Fenofibrate in Pharmaceutical Formulation by RP-LC-PDA

Vishnu P. Choudhari and Anna Pratima Nikalje

A simple, rapid and precise reversed-phase liquid chromatographic method is developed for simultaneous determination of Atorvastatin, Ezetimibe and Fenofibrate in their ternary mixture of commercial pharmaceutical preparations. This method, reported first time for a ternary mixture, uses a Kromasil C18, 250 × 4.6 mm, 5μm analytical column. Analytes were estimated by gradient elution with methanol/water at flow rate of 0.9 mL/min; the column temperature is 40°C and detector wavelength is 240 nm. The sample concentrations are measured on weight basis to avoid the internal standard. The method is validated and shown to be linear. The correlation coefficients for Atorvastatin, Ezetimibe and Fenofibrate are 0.9995, 0.9993 and 0.9996, respectively. The recovery values for Atorvastatin, Ezetimibe and Fenofibrate ranged from 99.7–101.1%, 99.8–101.3% and 99.7–101.7%, respectively. The relative standard deviation for six replicates is always less than 2%. This HPLC method is successfully applied to the simultaneous quantitative analysis of the title drugs in tablets.