A New Approach to the RP-HPLC Method for Simultaneous Estimation of Atorvastatin Calcium and Fenofibrate in Pharmaceutical Dosage Forms

Abstract

The present manuscript describes the development and validation of an isocratic reverse phase high-performance liquid chromatographic (RP-HPLC) method for the estimation of Atorvastatin calcium and Fenofibrate in raw material and tablet. Atorvastatin Calcium, Fenofibrate and Diclofenac (internal standard) were well separated using a reversed phase column and mobile phase consisting of acetonitrile:KH2PO4 (50 mM) (72:28 v/v) (pH 4.1). The mobile phase was pumped at 1.0 mL/min flow rate and atorvastatin calcium and fenofibrate were detected by UV-Vis detection at 260 nm. The retention time for atorvastatin calcium, Internal Standard and fenofibrate were 4.34, 5.35 and 12.05 min, respectively. The LOD and LOQ was found to be 1.95 and 4.80 µg/mL for atorvastatin calcium whereas for fenofibrate it was found to be 1.73 and 3.98 µg/mL in mobile phase. The developed method was validated by applying parameters as precision, accuracy, selectivity, reproducibility and system suitability tests.