Analytical Method Development and Validation of Solifenacin in Pharmaceutical Dosage Forms by RP-HPLC

Abstract

A new, accurate, precise, and robust HPLC method was developed and validated for the determination of solifenacin in tablet dosage form. The chromatographic separation was achieved on an Inertsil ODS 3V C 18 (150 mm × 4.6 mm, 5 μ m) stationary phase maintained at ambient temperature with a mobile phase combination of monobasic potassium phosphate (pH 3.5) containing 0.1% triethylamine and methanol (gradient mode) at a flow rate of 1.5 mL/min, and the detection was carried out by using UV detector at 220 nm. The performance of the method was validated according to the present ICH guidelines.