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 5µm , 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.
Metformin, RP HPLC, ICH Guidelines
Mr. Nilesh Nikam | Dr. Avish Maru | Dr. Anil Jadhav | Dr. Prashant Malpure