Development and Validation of Memantine Hydrochloride by RP-HPLC Method

Memantine hydrochloride is a class of N-Methyl-D-Aspartase receptor antagonist used in the treatment of Alzheimer's disease. The main aim of the present study was to develop a method to determine Memantine hydrochloride in tablet formulation which is simple, sensitive, precise, robust and economical as per ICH guidelines. The separation of the drug was achieved on Inertsil ODS 3V (250x4.6mm) 5μm column. The mobile phase used was a mixture of KH2PO4, Acetonitrile and methanol in the ratio 30: 40: 30. The detection of Memantine hydrochloride was done at λ max of 260nm. A good linear relationship with correlation co-efficient of 0.999 was obtained between the concentration range of 60μg/ml-140μg/ml and the LOD and LOQ values were 1.82μg/ml and 5.50μg/ml respectively. The method was also employed on the tablet formulation (Mentadem 10mg) and the recovery was found to be 99.15%.