ISSN: 2249–9504
CAS CODEN: IJPCDX

METHOD DEVELOPMENT AND VALIDATION OF FORCED DEGRADATION STUDIES OF METFORMIN HYDROCHLORIDE BY USING UV SPECTROSCOPY

Abstract

Author(s): Doredla Narasimha rao*, M. Prasada rao, J. Naga Hussain,S. Lakshmi Sumanoja and V.Rajeswararao

Metformin hydrochloride is the biguanide class of oral antihyperglycemics improves glucose tolerance in patients with type 2 diabetes, lowering both basal and postprandial plasma glucose. Metformin was freely soluble in Methanol, pH4and pH7 buffer. Methanol was choosen as a solvent. The drug has maximum absorbance at 237nm.The optical characteristic of drug was found to be Beer’s law limits 1-10 μg/ml, Correlation coefficient is 0.9989, Std error is 0.012089, Molar Absorbance is 37058.33.The drug sample was analyzed by UV spectroscopy using methanol as solvent and the average content of drug present in the formulation was found to be 100.4%. The % RSD of accuracy studies was found to be 99.7±0.352. The %RSD of precision was found to be 0.0209 to 0975.The% recovery of ruggedness was found to be 99.17±0.1636 and 99.69±0.5953.The pH degradation studies of tablet formulation were found to be less at pH 6-8. The force degradation studies of metformin tablet formulation was done on Stress degradation by hydrolysis under alkaline condition by using 0.1N NaOH was found to be 8.07% for 60min, 11.95% for 90min.Stress degradation by hydrolysis under acidic conditionby using 3N HCl and product degradation was found to be 9.75% for 60min and 12.79% for 90min. Dry heat induced degradation was done by using 700c temperature was found to be 20.94% for 48 hrs. Oxidative degradation was done by using hydrogen peroxide and product degradationwas found to be 12.65%for 15 min. Photolytic degradationwas found to be 10.53% for 3hrs and 14.36% for 6hrs.

Get the App