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ISSN 2063-5346
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METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF DONEPEZIL HYDROCHLORIDE USING DYE DRUG REACTION (EXTRACTIVE SPECTROSCOPY)

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Sunayana Kesharwani, Parul Mehta
» doi: 10.53555/ecb/2022.11.11.121

Abstract

The developed method for the estimation of Donepezil Hydrochloride through Dye Drug Reaction (Extractive Spectroscopy) using Bromocresol Green has demonstrated significant promise and reliability. The investigation into the linearity of the drug's reaction with Bromocresol Green revealed a robust correlation between the concentration of Donepezil Hydrochloride and the corresponding absorbance at 672nm. The exceptionally high correlation coefficient (r² = 0.999) attests to a linear relationship within the concentration range of 10-50 μg/ml.The recovery study, an imperative facet of method validation, showcased compelling outcomes. The mean recovery percentages at different concentration levels (80%, 100%, 120%) were closely aligned with 100%, underscoring the accuracy and dependability of the proposed method.Precision assessment, covering repeatability, intermediate precision (day-to-day and analyst-to-analyst), exhibited minimal standard deviations (% Mean±SD*) for Bromocresol Green across five different concentrations. This underscores the method's consistent and reliable performance under diverse conditions. The method's sensitivity was gauged through the determination of the Limit of Detection (LOD) and Limit of Quantification (LOQ). The obtained low values for LOD (0.75 mg/ml) and LOQ (2.10 mg/ml) underscore the method's adeptness in detecting and quantifying Donepezil Hydrochloride at low concentrations. The application of the developed method to analyze a commercial tablet formulation of Donepezil Hydrochloride yielded satisfactory results. The identified percentage concentration (98.40%) closely matched the labeled concentration (5 mg), affirming the method's suitability for pharmaceutical formulation analysis. In conclusion, the proposed method exhibits significant potential for accurate and reliable estimation of Donepezil Hydrochloride, making it a valuable tool in pharmaceutical analysis.

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