A Validated HPTLC Method for the Estimation of Donepezil HCL in Bulk and Its Tablet Dosage Form

Abstract

A simple, rapid, reliable and accurate HPTLC method has been developed for the quantitative
determination of Donepezil HCl in bulk and tablets. Various aliquots of the sample solution were
spotted automatically by means of camag Linomat 5 applicator on precoated silica gel 60 F254 on
aluminium sheet as stationary phase pre washed with methanol using Methanol: Chloroform (8:2 v/v)
as mobile phase. The spots were scanned at 254 nm. The Rf value of Donepezil HCl was 0.54 ± 0.02.
Calibration curves were linear in the range of 200-1000 ng spot-1
. The limit of detection and limit of
quantification were found to be 120 ng spot-1
and 165 ng spot-1
respectively. The suitability of this
method for the quantitative determination of compound was proved by validation in accordance with
requirements of pharmaceutical regulatory standards.