1Sri Indu Institute of pharmacy, Sheriguda (Village), Ibrahimpatan-501 510, RR Dist., Andhra Pradesh, India
2Dr. Reddy's Laboratories Ltd, Bachupally, Hyderabad, Andhra Pradesh, India
3United States Pharmacopeia-India Private Limited, ICICI Knowledge Park, Turkapally, Shameerpet, Hyderabad, India
*Corresponding Author E-mail: raveendra.ganduri@gmail.com
Online published on 6 March, 2013.
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.
Donepezil, Liquid Chromatography, Stress degradation, Method validation
