DEVELOPMENT AND VALIDATION OF HIGH PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR THE DETERMINATION OF DARIFENACIN HYDROBROMIDE

A simple, rapid, precise, specific and accurate RP-HPLC method has been developed for the determination of Darifenacin, a drug is of Urinary antispasmodic in bulk and pharmaceutical dosage form. Chromatography was performed on a Hibar® (250 x 4 mm, 5μm) LiChrosphere® 100 RP-18 in an isocratic mode with mobile phase Acetonitrile: 10mM Tetra Butyl Ammonium Hydrogen Sulphate (70:30%v/v) was used. The flow rate was 1.0ml/ min and effluent was monitored at 285 nm. The retention time was 3.108 min & linearity range was found to be 5 - 300 ?g/ml and the %RSD of the method was found to be less than 2%. The proposed method was statistically validated. The excipients present in the formulation do not interfere with the assay procedure. Key Words: Darifenacin hydro bromide, Validation, RP-HPLC