An RP-HPLC method is developed for the quantitative estimation of Darifenacin in tablet dosage form. Chromatography was carried on a Symmetry BDS C18 (4.6 x 100mm, 3.5 micrometer) column using pottassium dihydrogen phosphate (pH 7) and Acetonitrile as mobile phase in the ratio of 35:65%v/v at a flow rate of 0.8 ml/min with detection at 286 nm. The retention time of Darifenacin was about 3.359 min. The detector response is linear from 50-90 micrigram/ml of test concentration. The respective linear regression equation was found to be Y=7919.1x-44020. The Limit of detection and Limit of quantification were found to be 0.026 microgram/ml and 0.8 microgram/ml respectively. The percentage assay was found to be 100.8 % and percentage recovery for average of three different concentrations was found to be 101.9%, 101.7% and 100.8% respectively. The method was validated by determining its Linearity, accuracy, precision, intermediate precision LOD, LOQ and robustness according to ICH Q2B guidelines. The proposed method was found to be simple, fast, sensitive, linear, accurate, rugged and precise and hence can be applied for routine quality control of Darifenacin in bulk and in tablet dosage form.
Cite this article:
T. Sudha, Beena Elza Mathew. Development and validation of RP-HPLC method of analysis for the quantitative estimation of Darifenacin in tablet dosage forms. Research J. Pharm. and Tech. 5(4): April 2012; Page 518-522.