Abstract
Author(s): E.Manasa*, K.VanithaPrakash, P.RaviPratap andS.Susena
A simple, accurate, precise and rapid reversed-phase high performance liquid chromatographic (RP-HPLC) method has been developed and subsequently validated for the estimation of Darifenacin in bulk and Tablet Dosage form.The proposed method is based on the separation of drugs in reversed-phase mode using Waters HPLC 22695 model,Inertsil ODS column(250 x 4.6 mm, 5μm particle size).The optimum mobile phase consisted of methanol: phosphate buffer in the ratio of 80:20 v/v(Phosphate buffer pH 5.5) was selected as a mobile phase, flow rate of 1.0 ml/min and UV detection was set at 282 nm. The retention times was 3.21.The method was validated according to ICH guidelines. It was found to be accurate and reproducible. Linearity was obtained in the concentration range of 20-150μg/ml . The percentage RSD for precision and accuracy of the method was found to be less than 2%. The proposed method can be successfully applied in the quality control of bulk and pharmaceutical dosage forms.