METHOD DEVELOPMENT AND VALIDATION OF DONEPEZIL HYDROCHLORIDE BY RP-HPLC

A RP-HPLC for Donepezil hydrochloride in tablets was developed and validated. Donepezil hydrochloride is a reversible inhibitor of acetylcholinesterase, indicated for the treatment of mild to moderate dementia of the Alzheimer's type. The HPLC method was performed with a unisol reversed phase C18 column (150×4.6 mm, 3 µm) detection at 268 nm and a mixture of Acetonitrile: Water (50:50) as mobile phase. Typical retention time for Donepezil was 4.407 mins. The method was statistically validated for linearity, accuracy, precision and selectivity following ICH recommendations. Due to its simplicity and accuracy, the method can be used for routine quality control analysis. Keywords: Donepezil hydrochloride; Assay; HPLC; Validation.