SIMPLE AND SENSITIVE ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF METFORMIN HYDROCHLORIDE BY RP-HPLC

摘要

A simple, specific, accurate and isocratic reversed phase - HPLC method was developed and subsequently validated for the determination of Metformin Hydrochloride. Separation was achieved with an Inertsil - Extend - C18 HPLC column 250mm in length and having an internal diameter of 4.6mm. A mobile phase comprising 10m.mol 1-Octane sulfonic acid: Acetonitrile in the volume ratio o f (80:20) was developed. The detection was carried out using a PDA detector set at a wavelength of 232nm. Validation experiments were performed to demonstrate System suitability, specificity, precision, linearity and Range, Accuracy study, stability of analytical solution and robustness. The method was linear over the concentration range of 1-250μg/ml and get the correlation Regration (r2) 0.9995, showed good recoveries (100.25 - 101.13%), the relative standard deviations of intra and inter-day assay were 99.4% and 99.94% respectively. The method can be used for quality control assay of Metformin Hydrochloride