Sunday , 3 March 2024

A Simple Analytical Method Development and Validation for the Quantification of Darifenacin Hydrobromide in Pure and Its Tablet Dosage Form using UV-Spectrophotometry

A. Lakshmi Bhagya Sree*, B. Siva Sai Kiran, S. Muneer, K.B Chandra Sekhar
Department of Pharmaceutical Analysis, JNTUA- Oil Technological and Pharmaceutical Research Institute, Ananthapuramu-515001, A.P, India.

A simple, accurate and precise Zero order spectroscopy method was developed and validated for the estimation of Darifenacin Hbr bulk and pharmaceutical dosage forms.  Distilled water was used as a diluent to dissolve Darifenacin Hbr. The drug mixture was sonicated for 5 mins for the enhanced solubility. The maximum absorption was found to be at 234.0 nm, which was selected for the further analysis of Darifenacin Hbr bulk and its tablet dosage forms. The proposed method was validated according to ICH guidelines. The method showed high sensitivity with linearity range from 10 to 60μg/mL (r2=0.999). The limit of detection and limit of quantitation for estimation of Darifenacin Hbr was found to be 1.17μg/ml and 3.98957μg/ml, respectively. % Recovery was found to be in the range of 99.09% – 100.89 %. The reports expressed that the proposed method was found to be simple, precise, accurate and rapid for the estimation of Darifenacin Hbr bulk and tablet dosage form using UV spectroscopy.

Keywords: Darifenacin Hbr, Distilled Water, UV Spectroscopy, ICH Guidelines.

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