Abstract

SIMULTANEOUS ESTIMATION OF METFORMIN AND GLIPIZIDE BY RP-HPLC AND ITS VALIDATION

Sri Lakshmi D*, Jane T Jacob, Srinivas D, Satyanarayana D

ABSTRACT

A simple, accurate, economical and precise reverse phase high performance liquid chromatographic (RP-HPLC) method has been developed for the simultaneous determination of Metformin and Glipizide. The separation was achieved on Intersil C 18 column (250 x 4.6 mm, 5 μm) as stationary phase with a mobile phase comprising of Phosphate buffer pH(8.0):Acetonitrile (50:50) in an isocratic mode, at a flow rate of 2 ml/min. The detection was monitored at 257 nm. The retention time of Metformin and Glipizide were 2.41 min and 4.21 min respectively. The linearity was found to be in the range of 60-140 μg/ml and 3.6-8.4 μg/ml for Metformin and Glipizide respectively with correlation coefficient of 0.999. The proposed method was validated according to ICH guidelines for parameters like linearity, accuracy, precision and specificity. All validation parameters were within the acceptable range. The developed method was successfully applied for the estimation of Metformin and Glipizide in pure and pharmaceutical dosage form.

Keywords: Metformin, Glipizide, RP-HPLC, Validation, Simultaneous estimation, ICH guidelines.