Development and Validation of RP-HPLC Method for Simultaneous Determination of Donepezil and Memantine in their Tablet Dosage Forms

Srinivas Ganta*, Vidyadhara S
Chebrolu Hanumaiah Institute of Pharmaceutical Sciences, Chowdavaram, Guntur-522018, Andhra Pradesh, India.

A B S T R A C T
A simple, accurate and specific RP-HPLC method has been developed and validated for the simultaneous estimation of Memantine (MEM) HCl and Donepezil (DON) HCl in bulk and pharmaceutical dosage form. Chromatographic separation was achieved on Symmetry C₁₈ Column 250 X 4.8 Mm (5 µm) having mobile phase Methanol: Phsophate Buffer pH 4.6 adjusted with OPA in 70:30 ratio at a flow rate of 1 mL/min, ambient temperature and detection of both the eluents carried out by PDA detector at 273 nm. The retention time of MEM and DON was found to be 2.00 min. and 5.06 min respectively. Method was found to be linear over the range of 25-125 μg/mL for Memantine and Donepezil. Assay results of the marketed formulation were shown that %label claim of Memantine HCl and Donepezil HCl was found to be 100.96 ± 0.48 and 100.35±0.76 respectively. % recoveries of Memantine HCl and Donepezil HCl were obtained in the range of 99-100%. The developed method was found to be simple, precise and accurate and can be utilize as a quality control tool for the simultaneous estimation of both drugs from their pharmaceutical dosage form.
Keywords: Memantine HCl, Donepezil HCl, RP-HPLC, Symmetry Column