RP-HPLC method for the estimation of donepezil hydrochloride dosage form

Abstract

A simple and accurate methods to determine donepezil, in tablet dosage form, were developed and validated using liquid chromatography (LC). The LC separation was achieved on a Inertsil C8-3, 25 cm × 4.6-mm, 5 μ in the isocratic mode using buffer: methanol: triethylamine (550:450:5)v/v, adjusted to pH 2.50±0.05 with orthophosphoric acid, as the mobile phase at a flow rate of 1.0 mL/min. The methods were performed at 271 nm. In LC method, quantification was achieved with PDA detection over the concentration range of 20-60 μg/mL with mean recovery of 100.18±0.75%. The method was validated by determining its sensitivity, accuracy and precision. The proposed method is simple, fast, accurate and precise and hence can be applied for routine quality control of donepezil HCl in bulk and tablet dosage form.