2011•Asian Journal of Pharmaceutical AnalysisRequires access

Development and Validation of UV Spectrophotometric Method of Darifenacin Hydrobromide in Bulk and Tablet Dosage Form

D. Sridharan, Umarani A. Thenmozhi, L. Pavan Kumar, Aswani Dutt Chintalapati, M. Ramanaiah, Yelika Phanikishore

Abstract

A simple, accurate and specific UV spectrophotometric method was developed and validated for the estimation of Darifenacin hydrobromide in bulk and tablet dosage form. Analyte showed the absorption maxima in 0.1M Hydrochloric acid at 284nm. The percentage recovery of Darifenacin Hydrobromide was 99.69±0.14%. The developed method was validated with respect to linearity, accuracy, precision and specificity. Beer's law was obeyed in the concentration range of 20.00μg/mL to 46.50μg/mL, having line equation y=0.059x+0.0177 with correlation coefficient of 0.999. Results of the analysis were validated statistically as per ICH guidelines.

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Key concepts: Hydrobromide, Dosage form, Hydrochloric acid, Chromatography, Correlation coefficient, Analyte, Molar absorptivity, Mathematics