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ISSN 2063-5346
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STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF DONEPEZIL HYDROCHLORIDE USING RP-HPLC

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Sunayana Kesharwani, Parul Mehta
» doi: 10.53555/ecb/2022.11.11.122

Abstract

The present study outlines a straightforward and cost-effective stability indicating method for the quantitative determination of Donepezil Hydrochloride (DPH) using Reverse-Phase High-Performance Liquid Chromatography (RP-HPLC). The method utilizes a Thermo C18 column with dimensions of 250mm x 4.60mm and a particle size of 5μ, bonded with Octadecylsilane (C18). The mobile phase, comprising 50% Methanol and 50% Acetonitrile, ensures efficient separation. The analysis is performed at an ambient temperature with a flow rate of 1.0 ml/min. A sample size of 20 μl is injected into the system, and detection is carried out at a wavelength of 268nm. The retention time for Donepezil Hydrochloride is found to be 5.680±0.01 minutes. This method provides a reliable and sensitive approach for the determination of Donepezil Hydrochloride, making it suitable for stability-indicating assays in pharmaceutical formulations.

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