QUANTITATIVE ESTIMATION OF HYOSCINE BUTYL BROMIDE AND PARACETAMOL IN TABLET DOSAGE FORMS BY RP-HPLC METHOD

A new, simple, rapid and precise reverse phase high performance liquid chromatographic method has been developed for the validation of Hyoscine butyl bromide and Paracetamol in its pure form as well as in combined marketed formulation. Chromatography was carried out on a X bridge C18 (4.6mm×150mm) 5µm particle size column using a mixture of ACN: Methanol (70:30% v/v) as the mobile phase at a flow rate of 1.2ml/min, the detection was carried out at 260nm. The method was validated according to ICH guidelines for linearity, sensitivity, accuracy, precision, specificity and robustness. The method produce linear responses in the concentration range of 20-60mg/ml of Hyoscine butyl bromide and 10-30mg/ml of Paracetamol. The inter-day and intra-day precisions were found to be within limits. The method precision for the determination of assay was below 2.0%RSD. The method is useful in the quality control of bulk and pharmaceutical formulations. Keywords: Hyoscine butyl bromide and Paracetamol, RP-HPLC, Validation, Accuracy, Precision.