ISSN : 2663-2187

Development and Validation of High-Performance Thin Layer Chromatography Method for Quantitative Estimation of Febuxostat in Marketed Tablets Formulations

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Hemant Tawale ; Madhukar Tajne ; Amol Chandekar; Mohan Kale
» doi: 10.33472/AFJBS.6.Si3.2024.774-791

Abstract

Febuxostat commonly used antigout drug in clinics, this study demonstrated the use of a simple validated High-Performance Thin-Layer Chromatography method has been proposed for the quantitative determination of Febuxostat in a tablet dosage form. Objectives: To develop a validated High-Performance Thin-Layer Chromatography method for chromophoric drug Febuxostat and its tablet formulations. Methods: The separation was achieved on silica gel 60 F254 coated aluminum sheet as stationary phase using n-Hexane: Ethyl acetate (7.0: 3.0 v/v) as mobile phase which gave compact spots with Rf value 0.49 ± 0.02. Quantitative densitometric evaluation was done in absorbance-reflectance mode at 315 nm. The developed method was validated with respect to linearity, limits of detection and quantitation, accuracy, precision, specificity and robustness. Results: The response was found to be linear over concentration range of 100-600 ng/spot with correlation coefficients 0.997 and 0.996 and mean percentage recovery of the drug was observed to be 98.84 ± 0.537 and 98.44 ± 0.556 by peak area and peak height, respectively. Conclusion: The method was validated for linearity, accuracy, range, precision and robustness according to International Council on Harmonization Q2 (R1) guidelines. The method is simple, accurate, precise and was successfully applied to the assay of drug in tablet formulation

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