HPLC Analysis of Urapidil in Pharmaceutical Dosage Form

Abstract

A stability indicating HPLC method was developed for the determination of urapidil in pharmaceutical dosage form in presence of the degradation products. The chromatographic separation was achieved on an Inertsil ODS, 4.6 mm × 250 mm, 5 μm, column. The mobile phase contained a mixture of acetonitrile: 50 mM ammonium dihydrogen phosphate: triethanolamine (25: 75: 0.5, v/v, pH adjusted to 5.5 with orthophosphoric acid). The flow rate was 1.0 mL min^-1 and the detection wavelength was 270 nm. The method was validated for the parameters like specificity, linearity, precision, accuracy, LOD, LOQ and robustness. It shows an excellent linearity over range of 10 to 160 μg/mL (r² = 0.9997). The mean recovery of urapidil ranged from 99.16 to 100.04 % while intra and interday relative standard deviations were < 2.0 %. The method could be applied for stability testing as well as routine quality control analysis of urapidil in bulk drug and pharmaceutical formulation.