Development and Validation of a RP-HPLC Method for Estimation of Darifenacin Hydrobromide in Bulk and in Tablet Dosage Form

The present work describes a simple, precise and accurate HPLC method for estimation of darifenacin hydrobomide in bulk and in tablet dosage form. The separation was achieved by using Waters Sunfire C₁₈(4.6 X 250 mm) 5μm particle size column. The mobile phase consisted of 0.02M potassium dihydrogen phosphate buffer pH 7 adjusted with triethylamine: acetonitrile: methanol in the ratio of 40:30:30(v/v/v). Detection was carried out at 280 nm. The retention time of darifenacin hydrobromide was found to be 4.2 min respectively. The Limit of detection and limit of Quantification was found to be 2.112 μg/mL and 6.400 μg/mL respectively. The accuracy and reliability of the proposed method was ascertained by evaluating various validation parameters like linearity (10-100 μg/mL), precision, accuracy and specificity according to ICH guidelines. The proposed method provides an accurate and precise quality control tool for routine analysis of darifenacin hydrobromide in bulk and in tablet dosage form.