STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION OF METFORMIN AND GLIPIZIDE

Author(s): K. S. Nataraj*, A. Srinivasa Rao, R. Sowjanya, P. Indumathi4, Madhuri.Y

Abstract: A simple, specific and fast reverse phase High Performance Liquid Chromatographic method was developed for the simultaneous estimation of Metformin and Glipizide in a combined tablet dosage form. Optimum chromatographic separation was achieved within 8 minutes by use of Microsorb-MV C18 250×4.6mm, 5µm column as stationary phase with mobile phase consisting of Acetate buffer (pH 4.0): Acetonitrile (60:40 v/v) and at a flow rate of 1 ml/min. Detection was carried out at 257nm in HPLC. The method was validated in accordance with ICH guidelines. Response was a linear function of concentration over the range of 60-140 μg/mL for Metformin and 10-50 μg/mL for Glipizide in HPLC. Calibration curve was plotted and correlation co-efficient for the drug was found to be 0.998 for Metformin and 0.999 for Glipizide. The accuracy studies showed % recovery of Metformin in the range 100.42% and for Glipizide 100.39%. The developed RP-HPLC method can be applied successfully for the determination Metformin and Glipizide in a combined tablet dosage form. All the validation parameters were found within limits and the method was found to be economic, precise, accurate and specific.

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