A new HPLC method to determine Donepezil hydrochloride in tablets

A HPLC stability-indicating assay for Donepezil hydrochloride in tablets wa s developed and validated. Donepezil hydrochloride is a reversible inhibito r of acetylcholinesterase, indicated for the treatment of mild to moderate dementia of the Alzheimer's type. The HPLC method was performed with a reve rsed phase C18 column, detection at 268 ran and a mixture of methanol, phos phate buffer 0.02 M and triethylamine (50:50:0.5) as mobile phase. Typical retention time for Donepezil was 9 min. The method was statistically valida ted for linearity, accuracy, precision and selectivity following ICH recomm endations. Due to its simplicity and accuracy, the method can be used for r outine quality control analysis. (C) 2002 Elsevier Science B.V. All rights reserved.