Abstract

DETERMINATION OF ATORVASTATIN, EZETIMIBE AND FENOFIBRATE IN COMBINED PHARMACEUTICAL DOSAGE FORM USING HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY

K. L. N. N. S. V. K. Pavan Kumar*, A. Srinivasa Rao, P. Satyanarayana, G. Subhramanya Sastry

ABSTRACT

A simple, sensitive, accurate and precise high-performance liquid chromatographic method was developed and validated for the simultaneous determination of atorvastatin, ezetimibe and fenofibrate in bulk and in pharmaceutical formulations. An isocratic separation of atorvastatin, ezetimibe and fenofibrate was achieved on Phenomex C18 (250 x 4.6 mm; 5 μm particle size) analytical column at column oven temperature 30±1°C with a flow rate of 1ml/min. The mobile phase consisted of 0.1M KH2PO4, 0.1M K2HPO4 and methanol in the ratio of 30:20:50 v/v. The retention time of atorvastatin, ezetimibe and fenofibrate was found at 2.331, 3.885 and 8.669 minutes, respectively. Suitability, linearity, accuracy, precision, robustness and sensitivity of the method for the quantification of atorvastatin, ezetimibe and fenofibrate were proved by validation in accordance with the requirements laid down by International Conference on Harmonization guidelines. The proposed HPLC method is reliable, robust and can be used as quality control tool for the simultaneous quantification of atorvastatin, ezetimibe and fenofibrate in bulk and in pharmaceutical dosage form.

Keywords: Atorvastatin, Ezetimibe, Fenofibrate, isocratic HPLC system, validation, tablet dosage form.