A VALIDATION ANALYTICAL METHOD DEVELOPMENT FOR THE SIMULTANEOUS ESTIMATION OF METFORMIN HYDROCHLORIDE AND FENOFIBRATE IN PURE AND IN TABLET DOSAGE FORM

Abstract

Two simple, sensitive, specific, accurate, UV-spectroscopic and RP-HPLC methods are developed for the estimation of Metformin hydrochloride and Fenofibrate in pure and in tablet dosage form. The UV-spectroscopic first method was a determination using the simultaneous equation method at 237nm and 258nm over the concentration range of 3- 15µg/ml, 1-5µg/ml for Metformin hydrochloride and Fenofibrate respectively. The UV-spectroscopic second method was a determination using the derivative method at 221nm, 303nm over the concentration range of 9-45µg/ml and 3-15µg/ml for Metformin hydrochloride and Fenofibrate respectively. Calibration curve was linear with the correlation coefficient of 0.9999, 0.9998 and 0.9998, 0.9997 respectively. In the RP- HPLC method, separation of the drug in reverse phase mode using phenmenax Luna C18 column (150 mm x4.6 mm i.d. 5 µ). The mobile phase constituted of Methanol: Acetonitrile: 0.01M Ammonium acetate (60:30:10 % v/v/v) and flow rate 1.0 ml/min. Detection was performed at 256nm. The RT value of Metformin hydrochloride and Fenofibrate at 3.34 and 7.37 min. calibration curve was linear with correlation coefficient of 0.9994 and 0.9986 over a concentration range of 3-15 µg/ml and 1-5 µg/ml. the relative standard derivation (R.S.D)was found <2.0 % for both the methods. Both these methods have been successively applied to bulk and in tablet dosage form. The present methods were validated according to ICH guidelines.