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Research Journal of Pharmacy and Technology
Year : 2017, Volume : 10, Issue : 8
First page : ( 2743) Last page : ( 2749)
Print ISSN : 0974-3618. Online ISSN : 0974-360X.
Article DOI : 10.5958/0974-360X.2017.00487.5

Analytical Method Development and Validation for the analysis of Donepezil hydrochloride and its Related Substances using Ultra Performance Liquid Chromatography

Mahalingam V*, Vijayabaskar S, Kalaivani R.A, Somanathan T

Department of Chemistry, Vel's University, Pallavaram, Chennai, India

*Corresponding Author E-mail: mahalingam082@yahoo.in

Online published on 26 March, 2018.

Abstract

A novel, economic and time-efficient reverse-phase ultra-performance liquid chromatographic (RP-UPLC) method has been developed for the analysis of Donepezil hydrochloride in the presence of both impurities and degradation products generated by forced degradation. When Donepezil hydrochloride was subjected to acid hydrolysis, oxidative, base hydrolysis, photolytic, and thermal stress, observed degradation only in oxidative and base hydrolysis. The drug was found to be stable to other stress conditions. Various method development trails were performed for the separation of drug from impurities which was illustrated in Figure: 2, but separation was achieved on a Waters Acquity C18, 50 mm x 2.1mm, 1.7μ particle size column, UV detection at 286nm and a gradient elution of Trifluoroacetic acid, Acetonitrile and methanol as mobile phase for drug and its impurities and it was captured in Figure: 3. The method was validated for specificity, precision, linearity, accuracy, robustness and can be used in quality control during manufacture and for assessment of the stability samples of Donepezil hydrochloride. Total elution time was about 6 min and equilibration time of about 2 min which allowed analysis of more than 100 samples per day. The analytical method discussed in British Pharmacopeia was pH sensitive and not compatible to LC-MS analysis but the method reported in this study is more compatible to LC-MS which will be more suitable to perform LC-MS.

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Keywords

Donepezil hydrochloride, Impurities, Degradation products, UPLC method Validation.

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