Development and Validation of RP-HPLC Method for Simultaneous Estimation of Metformin and Miglitol in Bulk and Dosage Form

Attempts were made to develop RP-HPLC method for simultaneous estimation of Metformin and Miglitol from tablet. For the RP-HPLC method, Younglin (S.K.) Gradient system UV detector and C₁₈ column with 150 mm×4.6 mm i. d. and 5 μm particle size Acetonitrile: ph. Buffer (40: 60v/v) pH 3.2was used as the mobile phase for the method. The detection wavelength was 235 nm and flow rate was 0.7 ml/min. In the developed method, the retention time of Metformin and Miglitol sodium were found to be 3.4667 min and 7.4833 min. The developed method was validated according to the ICH guidelines. The linearity, precision, range, robustness was within the limits as specified by the ICH guidelines. Hence the method was found to be simple, accurate, precise, economic and reproducible.
A new, simple, accurate, precise, linear and rapid RP-HPLC method was developed and validated for the simultaneous estimation of Metformin and Miglitol in bulk drugs and formulations a s per ICH guidelines. Hence the method can be used for the routine and stability analysis in various pharmaceutical industries in bulk drugs and formulations.