SIMULTANEOUS DETERMINATION OF METFORMIN AND GLIBENCLAMIDE IN PHARMACEUTICAL PREPARATION BY RP-HPLC

A simple, rapid, precise and accurate reverse phase high performance liquid chromatographic method has been developed for the simultaneous determination of Metformin in combination with Glibenclamide. This method uses a Hypersil ODS C18 (250mm×4.6mm×5μ particle Size) analytical column, a mobile phase of Acetonitrile and buffer containing 0.05 M Ammonium acetate in the ratio 60:40 (v/v) and pH adjusted to 5.0 with ortho phosphoric acid. The instrumental settings are a flow rate of 0.7 mL/min and PDA detector wavelength at 256 nm. The retention times for Metformin and Glibenclamide are 4.44 min and 7.67, respectively. The method is validated as per ICH guidelines. The linearity range for Metformin and Glibenclamide were 500-1000 & 10-60 μg/mL respectively. The Percentage recovery for Metformin and Glibenclamide are ranged between 99.59–100.00 and 99.98–100.01 respectively. The correlation coefficients of Metformin & Glibenclamide were found to be 0.999, and 0.999, respectively. The relative standard deviation for six replicates was always less than 2%. The method is proved to be suitable for analysis of Metformin and Glibenclamide as a bulk drug and in pharmaceutical formulation without any interference from the excipients