Determination of metformin hydrochloride by reverse phase high performance liquid chromatography (RP-HPLC)

Author(s): Vijay Vikram Singh,Amit Kumar, A.Pandurangan, G.T.Kulkarni

A Rapid, precise, accurate, specific and simple HPLC method was developed for estimation ofmetformin hydrochloride in its commercial formulations. A High performance liquid chromatograph 10AT SHIMADZUSPD10A, using Phenomenex - Luna RP-18(2), 250X4.6mm, 5 mcolumn, with mobile phase composition of methanol: water and flow rate was 1 mL min-1 with UV detection at 233 nm. The retention time of metformin hydrochloride was 2.0min. The total elution time was less than 5minutes. Linearity was observed over concentration range of 4-20 µg mL-1 for metformin hydrochloride. The Limit of detection and Limit of quantitation formetformin hydrochloride was found to be 20.895 µg mL-1 and 63.319 µg mL-1 respectively. The accuracy of the proposed method was determined by recovery studies and found to be 101.48%and 102.24%formetformin hydrochloride respectively.Commercial formulations and laboratory preparedmixtureswere successfully analyzed using the developed method. The proposed method was validated for various ICH parameters like linearity, limit of detection, accuracy, precision, ruggedness, robustness, and system suitability.

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