STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION OF GLIBENCLAMIDE AND METFORMIN IN BULK AND PHARMACEUTICAL DOSAGE USING RP-HPLC
*M. Hymavathi, P. Sunitha and Dr. Vijaya Kuchana
ABSTRACT
Objective: A New method was established for simultaneous estimation of Metformin and Glibenclamide by RP-HPLC method and Its force degradation study. Methods: Chromatographic separations were carried using Agilent C8, (150 X3834.6 mm, 5μm) column with a mobile phase composition of 0.1 M 0.1 M Ammonium acetate (0.1 M): Methanol (70:30) have been delivered at a flow rate of 1ml/min and the detection was carried out using waters HPLC auto sampler, separation module 2695 HPLC system with PDA detector at wavelength 254 nm. Results: The retention time for Metformin and Glibenclamide were 3.17 and 8.10 minute respectively. The correlation coefficient values in linearity were found to be 0.999 and concentration range 40-60 μg/ml for Metformin and 40-60 μg/ml for Glibenclamide respectively. For accuracy the total recovery was found to be 100.63 % and 101.79 % for Metformin and Glipalamide. LOD and LOQ for Metformin 2.936 and 9.78. LOD and LOQ for Glibenclamide 2.92 and 9.75. Metformin and Glibenclamide were subjected to stress conditions including acidic, alkaline, oxidation, photolysis and thermal degradation. Metformin and Glibenclamide are more sensitive towards acidic and Thermal degradation. Conclusion: The results of study showed that the proposed RP‐HPLC method is a simple, accurate, precise, rugged, robust, fast and reproducible, which may be useful for the routine estimation of of Metformin and Glibenclamide in tablet dosage form.
Keywords: Metformin, Glibenclamide, RP?HPLC, Simultaneous estimation.
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