Thursday , 25 April 2024

RP-HPLC Method Development and Validation for the Simultaneous Estimation of Donepezil and Memantine in Pure and Pharmaceutical Dosage Form

Dr. Gampa Vijay Kumar*1, Dr. D. Naresh2, M.Kirthi3
1Professor and Head, Dept. of Pharmacy, KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India.
2,3KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India.

A B S T R A C T
On the basis of experimental results, the proposed method is suitable for the quantitative determination of memantine and donepezil in pharmaceutical dosage form. The method provides great sensitivity, adequate linearity and repeatability. The estimation of Memantine and donepezil was done by RP-HPLC. The Phosphate buffer was pH 4.6 and the mobile phase was optimized which consists of MEOH: Phosphate buffer mixed in the ratio of 70:30 % v/ v. A Symmetry C18 (4.6 x 150mm, 5µm, Make XTerra) column used as stationary phase. The detection was carried out using UV detector at 273 nm. The solutions were chromatographed at a constant flow rate of 1.0 ml/min. the linearity range of Memantine and donepezil were found to be from 25-125 µg/ml. Linear regression coefficient was not more than 0.999.The values of % RSD are less than 2% indicating accuracy and precision of the method. The percentage recovery varies from 97-102% of Memantine and donepezil LOD and LOQ was found to be within limit. The proposed method is precise, simple and accurate to determine the amount of Memantine and donepezil in formulation. High percentage of recovery shows that the method is free from the interference of excipients used in the formulation. So the method can be useful in the routine quality control of these drugs.
Keywords: Memantine and donepezil was done by RP-HPLC

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