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.