Analytical method development and validation for simultaneous estimation of memantine and donepezil in pharmaceutical dosage form by RP-HPLC Parthiban C.*, Vislavath Anjali, Vollala Supriya, Dhontam Bhanu Priya, Sadineni Sri Nithya, Sudhakar M. 1Professor, Malla Reddy College of Pharmacy, Maisammaguda, Dhulapally, Secunderabad - 500100, Telangana, India 2Department of Pharmaceutical Analysis, Malla Reddy College of Pharmacy, Secunderabad - 500100, Telangana, India *Corresponding Author E-mail: parthi1617@gmail.com
Online Published on 23 January, 2024. Abstract A simple, precise and accurate method was developed for the simultaneous estimation of memantine and donepezil. The chromatogram was performed with a Thermo scientific C18 (150 × 4.6mm, 5μm). At a flow rate of 1ml/min, mobile phase used is 70:30% v/v mixture of buffer pH 4.5 and ACN. The best detection wave length for memantine and donepezil was at 265nm. The retention time was 2.325 and 3.088minutes. Assay results of 100.87 percent and 99.31 percent, %RSD values are below 2 and linearity R2 values are 0.999 for both the drugs. The strategy appears to have been compact and worth, and it is proper for everyday Quality Control Estimates in Industry sections since Maintenance Times are Diminishing and that Gathered Code was reducing. Thus, the developed method was validated according to 1CH guidelines for routine analysis of the sample. Top Keywords Donepezil, Memantine, Validation, Buffer and ICH Guidelines. Top |