New RP-HPLC Method for Estimation of Donepezil Hydrochloride in Pharmaceutical Formulations

Author(s): B. S. Sastry, S. Gananadhamu, C. Devadasu and K. Balaji

 A simple and sensitive HPLC method has been developed for the estimation of donepezil hydrochloride in pharmaceutical formulations. donepezil hydrochloride is a reversible inhibitor of acetyl cholinesterase, indicated for the treatment of mild to moderate dementia of the Alzheimer’s type. The

HPLC method was developed by using Phenomenex Luna C 18 column (250 mm length, 4.6 mm internal diameter and 5 9m particle size) and a 50 : 50 v/v mixture of acetonitrile and 0.025 M phosphate buffer (pH adjusted to 7.00 after addition of 5.0 mL of triethylamine) as a mobile phase. The analyte was
monitored with UV detector at 228 nm. Typical retention time for donepezil hydrochloride was found to be 12.78 min. and the total run time for chromatography was maintained up to 18 min. The method was statistically validated for its linearity, accuracy and precision. Due to its simplicity and accuracy, the method can be used for routine quality control of donepezil hydrochloride in pharmaceutical formulations.

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