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
DOI No:

ABSTRACT:
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.
KEYWORDS:
Donepezil, Liquid Chromatography, Stress degradation and Method validation.
Cite:
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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