Metformin hydrochloride

RP-HPLC method has been developed for the simultaneous determination of Metformin hydrochloride and Miglitol in pharmaceutical dosage form. The method is simple, precise and accurate. RP-HPLC method is based on the separation eluted using a mobile phase mixture of methanol and phosphate buffer (adjusted to pH 4.5 using ortho phosphoric acid) in a ratio of 60:40 %v/v at a flow rate of 1.0ml/min. The detection was made at 218 nm. The retention times were 3.84 for MET and 5.07min for MIG. Calibration curve was linear over the concentration range of 50-150μg/ml for Metformin hydrochloride and 5-15 μg/ml for Miglitol. The accuracy of the method was assessed by recovery studies and was found to be 99.69% for Metformin hydrochloride and 99.80% for Miglitol. The developed method was validated as per the ICH guidelines parameters like Linearity, precision, accuracy, robustness, LOD and LOQ. The results were validated as per ICH Q2 R1 guideline and were satisfactory.