Development and Validation of Rp-hplc Method for Simultaneous Determination of Metformin and Miglitol in Bulk and Pharmaceutical Formulation

Objective: The aim of the present study was the development and validation of a simple, precise, rapid, accurate and specific RP-HPLC method in which the peaks will be appeared with high resolution and short period of retention time as per ICH Guidelines. Methods: Simple, sensitive, specific, accurate reversed phase high performance liquid chromatographic method was developed for the simultaneous determination of Metformin and Miglitol in bulk drug and in combined dosage forms. RP-HPLC separation was achieved on a kromasilC18 Results: The retention times of Metformin and Miglitol were found to be 3.86min and 7.56min respectively. Linearity was established for Metformin and Miglitol in the range of 200-500μg/ml and 20-50μg/ml, respectively. The percentage recoveries for Metformin and Miglitol were found to be in the range of 98.12-101.53% and 98.06-101.8% respectively. This method can be successfully employed for simultaneous quantitative analysis of Metformin and Miglitol in bulk drugs and formulations. (4.6 x 150mm, 5 μ) under an Isocratic Mode. The mobile phase composed of Phosphate Buffer (60%) (whose pH was adjusted to 5.3 by using potassium hydroxide) & Methanol (40%) [HPLC Grade]. The flow rate was monitored at 0.9 ml per min. The wavelength selected for the detection was 238 nm. Conclusion: 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 as per ICH guidelines. Hence the method can be used for the routine and stability analysis in various pharmaceutical industries in bulk drugs and formulations.