Abstract

DEVELOPMENT AND VALIDATION RP-HPLC-PDA METHOD FOR THE DETERMINATION OF METFORMIN IN BULK AND DOSAGE FORM

Devendra Kumar*, Saurabh Srivastava, Rachumallu Ramakrishna, Rakesh Kumar Dixit

ABSTRACT

A simple, sensitive, precise and accurate reversed phase liquid chromatographic method has been developed for the estimation of metformin from bulk dosage form. The method was developed and validated using a Thermo Accuacore Hillic (150 × 4.6 mm, 5 μm) column with a mobile phase consisting 20 mM sodium acetate buffer and acetonitrile (45:55, v/v with pH-4 ); at a flow rate of 0.7 mL min-1. The PDA detection was achieved at 236 nm, over a wide dynamic range of 0.039 to 1.25 μg mL-1. The retention time of metformin was 3.9 minutes. The method was successfully validated in accordance to ICH guidelines acceptance criteria for specificity, linearity, accuracy, precision, robustness, ruggedness and system suitability. Intra-day and inter-day assay accuracy and precision of the metformin were less than 2%, and the average recovery were in the range of 98–102%. Metformin was subjected to the stress conditions of oxidation, acid and base hydrolysis and thermolysis. The method was successfully applied for analysis of metformin in the presence of excipients in commercially available tablet and bulk dosage form

Keywords: Metformin, HPLC, Hillic column, dosage form