Analytical Method Development and Validation of Metformin Hydrochloride by using RP-HPLC with ICH Guidelines

A simple and reproducible method was developed for Metformin (MET) by Reverse Phase High Performance Liquid Chromatography (RP-HPLC). Metformin was separated on C18 column 4.6x250mm, particle size 5m, using combination of phosphate buffer with pH of 3.0 and Methanol at the UV detection of 238nm. Isocratic elution of phosphate buffer with pH of 3.0 and Methanol was used as a mobile phase with various ratios and flow rates, eventually 30:70 v/v phosphate buffer with pH of 3.0 and Methanol was being set with the flow rate of 1mL/min. The statistical validation parameters such as linearity, accuracy, precision, inter-day and intra-day variation were checked, assay studies of Metformin were within 98% to 102% indicating that the proposed method can be adoptable for quality control analysis of Metformin.