Journal :   Asian Journal of Research in Chemistry

Volume No. :   4

Issue No. :  10

Year :  2011

Pages :   1508-1512

ISSN Print :  0974-4169

ISSN Online :  0974-4150


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New Comprehensive HPLC Assay Method for Donepezil Hydrochloride

Address:   Ravi Kumar Vejendla1, G. Hemanth Kumar1, G. Raveendra Babu2*and J.Srinivasarao3
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

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 and Method validation.
Ravi Kumar Vejendla, G. Hemanth Kumar, G. Raveendra Babu, J.Srinivasarao. New Comprehensive HPLC Assay Method for Donepezil Hydrochloride. Asian J. Research Chem. 4(10): Oct., 2011; Page 1508-1512.
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