Stability indicating rapid RP-HPLC method for the determinationof Drotaverine hydrochloride, Domperidone and paracetamol inpharmaceutical dosage forms

[摘要] A simple and precise high performance liquid chromatographic method has been developed andvalidated for the simultaneous determination of drotaverine hydrochloride, domperidone andparacetamol in a binary tablet formulation containing drotaverine hydrochloride-paracetamoland/or domperidone-paracetamol. Chromatography was carried out at 25°C on a4.6mm×150mm, 5μm Symmetry shield RP 18 column with the isocratic mobile phase of 0.02Maqueous potassium dihydrogen phosphate buffer (pH 7.5) and acetonitrile (40:60, v/v) at a flowrate of 0.5 ml/min. Drotaverine hydrochloride, domperidone and paracetamol were separated inless than 10 min with good resolution and minimal tailing, without interference of excipients.The method was validated according to ICH guidelines and the acceptance criteria for accuracy,precision, linearity, specificity and system suitability were met in all cases. The method waslinear in the range of 192–448μg/ml for drotaverine hydrochloride, 24–56μg/ml fordomperidone and 12–28μg/ml for paracetamol.

[学科分类] 药理学