Concurrent Quantification of Memantine and Donepezil via RP-UPLC with Stability Indicating Feature: Method Development and Validation

Abstract

The primary goal of the proposed study was to establish and validate an efficient, sensitive, specific, and simple RP-UPLC method for concurrent analysis of Memantine and Donepezil in pure mixed powder and fixed-dose combined tablets. AQUITY UPLC instrument with TUV detector was selected to develop the present approach. To separate or resolute Memantine and Donepezil with significant system sutability, X bridge C18 column (100x 2.1mm,1.8m) and a mobile phase of KH2PO4: ACN (70:30 v/v) with 0.3mL/min flow rate were used. The eluted Memantine and Donepezil were detected at 257nm. The optimized approach was validated in consideration with ICH Q2R1 provisions. Forced degradation studies were carried out to confirm its stability indicating property of the optimized method was confirmed by implementing the forced degradation studies to Memantine and Donepezil solutions.The retention times of Memantine and Donepezil were observed at 1.17and 1.59min correspondingly. The Linearity was ensured for Memantine and Donepezil in the range 3.5-21µg/mL and 2.5-15 µg/mL correspondingly. The intraday and inter-day precision was confirmed by assessing %RSD, which resulted in the range of 0.23 to 1.03. The recovery of both Memantine and Donepezil in spiked samples was in the range of 99% - 100.30%. The obtained results confirming the established method’s specificity, sensitivity and competency. Investigation of Memantine and Donepezil in the incidence of several strained or forced environments confirms stability representing feature of the stated approach. The established RP-UPLC approach is enormously effective in separation and analysis of Memantine and Donepezil. Hence, the expected approach has significant credit in quality control unit of pharmaceutical segment.