Novel RP-HPLC Method Development and Validation of Metformin HCl and Repaglinide in bulk and Tablet dosage form

Abstract

To quantify repaglinide and metformin HCl in largeand combination tablet dosage form simultaneously by RP-HPLC, a simple, precise, and accurate approach has been developed. The Chromatographic conditions employed were Agilent C18 column (150×4.6mm, 5µ) column using a Methanol: Water mixture in gradient mode as the mobile phase at a flow rate of 0.6 ml/min, λmax was found to be 245.5 nm in UV Spectrophotometer. The Retention time (Rt) of the Metformin HCl and Repaglinide was found to be 1.575 and 2.564min respectively. The established techniquewas confirmed as per ICH Q2 (R1) strategies. The method produces linear responses in the concentration range of 5:0.02-150:0.6 µg/ml for the RP-HPLC method. For the RP-HPLC procedure, a correlation coefficient value of 0.999 was found. As a result, the recomendedmethod may be employedto successfully quantify Metformin HCl and Repaglinide in bulk and combination tablet dosage form.