Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF METFORMIN HYDROCHLORIDE BY RP-HPLC IN DRUG SUBSTANCE

Merugu Manasa* and Peddiboina Gopi

Abstract

A simple, accurate, precise and rapid Reversed-Phase High Performance Liquid Chromatographic (RP-HPLC) method has been developed and subsequently validated for the estimation of Metformin Hydrochloride in pure form. The proposed method was separation of Metformin by reversed-phase mode using SHISEIDO C-18 analytical column (250×4.6 mm I.D., 5 μm particle size) and mobile phase consisted of Acetonitrile: Phosphate buffer PH-7(50:50 v/v). Flow rate of 1.0 ml/min and UV detection was set at 254 nm were selected peak produced for Metformin Hydrochloride at retention time of 2.27 min. The method was validated according to ICH guidelines. Linearity was obtained in the concentration range of 10-35 μg/ml. Mean percent recovery of samples at each level for drug was found in the range of 100.93%, %RSD was 1.47, LOD and LOQ were 0.011179 & 0.033876 respectively. By change in parameters like flow rate and temperature system suitability parameters were within the limit, it indicates that the method was robust.

Keywords: Metformin Hydrochloride, HPLC, Method development, Validation, Acetonitrile, Phosphate buffer and C-18 column.