Estimate Hyoscine Butylbromide and Mefenamic Acid by RP-HPLC method development and accelerated stability study in pure and combine dosage form

Abstract

The aim of the present study was to develop and validate stability indicating HPLC method for simultaneous estimation of Hyoscoine butyl bromide (HBB) and Mefenamic acid (MEF). HPLC method for simultaneous analysis of both drugs was developed and validated according to ICH guideline. Efficient chromatographic separation was achieved on ODS column C18 (250 mm × 4.6 mm, 5 μm) using the optimized mobile phase. Stability indicating assay method was carried out by different stress degradation conditions. In HPLC method, the Retention time for HBB and MEF was 3.21 and 5.07 min using optimized mobile phase potassium dihydrogen phosphate buffer (pH 5.0) and methanol (60:40 % v/v) with a flow rate of 1 ml/min. The multiple wavelength UV detector was set at a 237 nm for measurement of all compound. Quantification based on measuring the peak areas. The degradation of HBB, MEF and Formulation was shown to be highest in alkaline condition. Linearity was observed in concentration range of 1- 3μg/ml and 12.5-37.5 μg/ml for HBB and MEF respectively. All validation parameters were within the acceptable range. Moreover, the % RSD for repeatability, inter and intraday precision was found to be within the range, which reveals that the method is precise. Accuracy study of the drug in marketed preparation also report in the limit. Assay of the dosage form finalized the applicability of this method for estimation of Hyoscine Butylbromide and Mefenamic Acid tablet dosage form.