Stability Indicating RP-HPLC Method for the Estimation of Memantine Hydrochloride in Pure and Pharmaceutical Dosage Form

A simple, fast and precise stability indicating RP - HPLC method was developed for the quantification of Memantine HCl in pure and pharmaceutical dosage form. The quantification was carried out using Intersil ODS C18 4.6 X 150mm, 5μm enhanced polar selectivity column and mobile phase comprised of 0.2M sodium dihydrogen phosphate&0.1M disodium hydrogen phosphate buffer of pH adjusted to 3 with orthophosphoric acid and Acetonitrile in proportion of ratio 50:50 and degassed under ultrasonication. The flow rate was 1ml/min and the effluent was monitored at 272nm. The retention time of Memantine HCl was found to be 3.337 min. The method was validated in terms of linearity, precision, accuracy, specificity, robustness, limit of detection and limit of quantitation in accordance with ICH guidelines. Linearity of Memantine was in the range of 20 - 120 μg/mL. The percentage recoveries of Memantine were 99.66% to 102.5% from the tablet formulation. The stability - indicating capability was established by forced degradation experiments. The proposed method is suitable for determination of Memantine HCl in pharmaceutical dosage form.