Abstract

SIMPLE RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF METFORMIN HYDROCHLORIDE AND FENOFIBRATE IN TABLET DOSAGE FORM

Sushma Edukulla*, Haritha Reddy Nagidi, Samidha Thumma, Sreekanth Gandhe

Abstract

A simple, specific, accurate and precise reverse phase high pressure liquid chromatographic method has been developed for the simultaneous determination of Metformin Hydrochloride (MET) and Fenofibrate (FENO) in tablet dosage form by using Hypersil Octadecylsilane column (250mm x4.60mm, 5μm). The samples were analyzed by using Methanol : Buffer (0.5% Ammonium dihydrogen orthophosphate adjusted to pH-3 using orthophosphoric acid)- 55 : 45v/v as a mobile phase at the flow rate of 1.0 ml/min in isocratic mode and detection wavelength is 226 nm. Both the drugs were eluted within 5 minutes and gave sharp peaks with high theoretical plate count and low tailing factor. The retention time for Metformin Hydrochloride and Fenofibrate was found to be 2.484 and 4.616 min respectively. The validation was carried according to ICH guidelines. Calibration curve was linear with correlation coefficient of 0.998 and 0.999 over a concentration range of 20-100μg/ml and 6.4-32μg/ml for Metformin Hydrochloride and Fenofibrate respectively. The percent recovery was 99.59 for Metformin Hydrochloride and 99.54 for Fenofibrate indicating accuracy and reliability of method. So the method can be used for estimation of combination of these drugs in tablet dosage form.

Keywords: