A VALIDATION ANALYTICAL METHOD DEVELOPMENT FOR THE SIMULTANEOUS ESTIMATION OF METFORMIN HYDROCHLORIDE AND FENOFIBRATE IN PURE AND IN TABLET DOSAGE FORM
Journal Title: International Research Journal of Pharmacy (IRJP) - Year 2011, Vol 2, Issue 12
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.
Authors and Affiliations
D. Nagavalli, S. Vijayashanthi, R. Lakshmisundram
Keywords
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