New Comprehensive HPLC assay Method for Donepezil Hydrochloride

A novel stability indicating liquid chromatographic assay method was developed and validated as per ICH guidelines for the quantitative estimation of Donepezil in tablet formulation. An isocratic reverse phase LC-method was developed using Zorbax SB C18, 150 x 4.6mm, 5μm column and a mobile phase comprising of a mixture of water: acetonitrile (68:32), pH adjusted to 4.5 with trifluoro acetic acid. The detector set at 229nm with flow rate of 1.0mL min^-1. The method is linear between 5 μg mL^-1 to 25 μg mL^-1 and the limit of detection (LOD) is 0.5 μg mL^-1. The Accuracy of the method was found to be in the range of 99.70% to 100.26%. The mean Inter and Intraday assay Relative Standard deviation (%RSD) were less than 0.69%. The Proposed method was found to be Linear, precise and accurate for the quantitative estimation of Donepezil in tablet formulations and can be used for commercial purposes.