Abstract

A NOVEL AND VALIDATED RP-HPLC METHOD DEVELOPMENT FOR THE DETERMINATION OF ATORVASTATIN AND FENOFIBRATE IN BULK AND PHARMACEUTICAL FORMULATIONS

Kundurthi Bhagyarekha*, Ch. M. M. Prasada Rao and D. Dhachinamoorthi

ABSTRACT

A novel, simple, rapid and precise reverse phase isocratic high performance liquid chromatographic method has been developed for the simultaneous determination of Atorvastatin and Fenofibrate in bulk and pharmaceutical formulations. Determination of drugs in their formulations were done with a Agilent 100-5C18 Column 250mm × 4.6mm using mobile phase of composition Acetonitrile, Methanol and Water (50:40:10 v/v) the flow rate was 1.2ml/min and the effluent was monitored at 273nm. The retention time of Atorvastatin was observed at 1.6min. The retention time of Fenofibrate was found to be 5.0min. The method was found to be linear over a range of 10-50g/ml for both Atorvastatin and Fenofibrate. The method was validated according to the guidelines of International Conference on Harmonization (ICH) and was successfully applied in the estimation of commercial formulations.

Keywords: Atorvastatin, Fenofibrate, RP-HPLC, Method Validation.