Development and Validation of Stability Indicating Reverse Phase High Performance Liquid Chromatographic Method for Estimation of Donepezil Hcl from Bulk Drug

Stability of Donepezil Hydrochloride(DONE) was investigated using stability indicating Reverse phase high performance liquid chromatography (RP-HPLC) utilizing C-18 column and mobile phase containing Acetonitrile: Water (pH 3.5) in ratio of 40:60 at flow rate of 1 ml min-1. Peaks of donepezil and degradation products were well resolved at retention times < 7 min. Stability was performed in 0.1N hydrochloric acid, 0.1N sodium hydroxide, 3 % hydrogen peroxide, neutral, photolytic and dry heat conditions. Fast hydrolysis was seen in alkaline condition as compared to oxidative and neutral conditions. Methods was validated with respect to linearity, precision, accuracy, specificity and robustness LOQ and LOD. It was also found to be stability indicating, and therefore suitable for the routine analysis of Donepezil hydrochloride in the pharmaceutical formulation.