Liquid Chromatographic Method for the estimation of Donepezil Hydrochloride in a Pharmaceutical Formulation

A stability indicating HPLC method for the estimation of 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 reversed phase C18 column (250 mm X 4.6 mm id, 5mm particle size), detection at 230 nm and a mixture of methanol, water and ortho phosphoric acid for pH adjustment at 4 (60:40) as mobile phase. Typical retention time for donepezil was 4.23 min. Forced degradation studies were carried out. The drug was found to be stable to the dry heat, photo-degradation, oxidation, basic, and acidic condition attempted which indicate drug is highly stable. Quantification was achieved with ultraviolet detection at 230 nm over the concentration range 2 – 60μg/ml with range of recovery 99.14 – 100.84 % for donepezil by the RP-HPLC method. 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.