Abstract

DEVELOPMENT AND VALIDATION OF RP-UPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF MEMANTINE AND DONEPEZIL IN BULK AND PHARMACEUTICAL DOSAGE FORMS

Boya Srikanth*, Dr. M. Ajitha

Abstract

A rapid and reliable RP-UPLC method was developed for the simultaneous estimation of Memantine and Donepezil in bulk drugs and combined dosage forms. Chromatographic separation was carried out on a C18 column (100 mm × 4.6 mm, 3 μm) using Solution A (Buffer:Methanol, 70:30, v/v) and Solution B (Acetonitrile:Methanol:Water, 90:5:5, v/v) as the mobile phase at a column temperature of 30°C. Detection was performed at 257 nm. Memantine and Donepezil showed retention times of 1.175 min and 1.666 min, respectively. System suitability results were within acceptable limits, with %RSD values of 0.65 and 0.80. The method exhibited excellent linearity (R² = 0.9995 and 0.9999) and high accuracy with recoveries between 98.87–100.05%. Stress degradation studies indicated that both drugs were stable under acidic, alkaline, oxidative, thermal, photolytic, and neutral conditions, confirming the method as stability-indicating. The proposed RP-UPLC method is simple, fast, robust, and validated as per ICH guidelines, making it suitable for routine quality-control analysis of Memantine and Donepezil.

Keywords: Memantine, Donepezil, RP-UPLC, Linearity, Accuracy, Precision, Stress Degradation.