Abstract

ANALYTICAL METHOD VALIDATION OF STABILITYINDICATING HPLC METHOD FOR DETERMINATION OF ASSAY OF MEMANTINE HYDROCHLORIDE TABLETS

This paper deals with the development and validation of stability indicating high performance liquid chromatographic method for the quantitative determination of Memantine hydrochloride. Study of an analytical method for the determination of Memantine hydrochloride drug and also validate the method as per the ICH guideline and required acceptance criteria. The method was developed by using Hypersil BDS C8 column (250×4.6 mm id, 5 µm particle sizes) containing mobile phase Buffer and acetonitrile in ratio (65:35). The flow rate was set at 1.0 mL/minute and the injection volume was 10μL. The run time of injection is near about 15 min. In this method use Waters HPLC system with Reflective Index detector. The linearity of method was 50 % to 100 %, the correlation coefficient was found to be 0.9999. Eluents were monitored by reflective index detector. The liquid chromatographic method was validated with respect to specificity, precision (% RSD about 0.71%). Stability an analytical solution (% deviation from initial area count found in limit ±2%)