RP-HPLC method for estimation of miglitol and metformin hydrochloride in pharmaceutical formulation

A simple, rapid and sensitive RP-HPLC method was developed for the quantitative determination of metformin hydrochloride and miglitol in combined tablet dosage form. The chromatographic analysis was carried out on Phenomenex Gemini C18 (250 x 4.6 mm, 5 μm) with mobile phase containing methanol: TEA buffer (50:50 v/v). The flow rate of mobile phase was 1.0 mL/min and effluents were monitored at 272 nm. The retention times of miglitol and metformin hydrochloride were 2.121 min and 3.643 min, respectively. The proposed method was validated with respect to linearity, accuracy, precision, specificity and robustness.The method was found to simple, rapid and sensitive and was successfully applied to the estimation of metformin hydrochloride and miglitol in combined dosage form.