Abstract

STABILITY INDICATING RP – HPLC METHOD FOR DETERMINATION OF GLIBENCLAMIDE & METFORMIN HCL IN PURE AND PHARMACEUTICAL FORMULATION

Bhavika R. Chavhan*, Vaishali C. Kulkarni, S. R. Bavaskar, Dr.S. D. Barhate

Abstract

A simple, rapid and accurate and stability indicating RP-HPLC method was developed for the determination of Glibenclamide & Metformin HCL in pure and tablet forms. The method showed a linear response for concentrations in the range of 10-50μg/ml & 500-2500μg/ml using Methanol: Water solution in the ratio (70:30) as the mobile phase with detection at 226 nm and a flow rate of 1 ml/min and the retention time for Glibenclamide and Metformin was found to be 9.2 and 3.8 min respectively.. The value of correlation coefficient were 0.999, &0.998. The method was validated for precision, recovery, ruggedness and robustness. The drug undergoes degradation under acidic, basic, peroxide and thermal degradation conditions. All the peaks of degraded product were resolved from the active pharmaceutical ingredient with significantly different retention time. As the method could effectively separate the drug from its degradation product, it can be employed as a stability indicating one.

Keywords: Glibenclamide, Metformin HCL, RP-HPLC, Degradation studies.