Abstract

STABILITY INDICATING CHROMATOGRAPHIC METHOD DEVLOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF HYOSCINEBUTYLBROMIDE AND MEFENAMIC ACID IN TABLET BY HPLC.

Viral S. Patel*, Bhumi R. Patel, Jaymin G. Patel, Rinku B. Patel and Nupur A. Mewada

ABSTRACT

A simple, rapid, economical, precise and accurate Stability indicating RP-HPLC method for simultaneous estimation of Hyoscine Butylbromide and Mefenamic acid In Their Combined Dosage Form has been developed. A reverse phase high performance liquid chromatographic method was developed for the simultaneous estimation of Hyoscine Butylbromide and Mefenamic acid. In Their Combined Dosage Form has been developed. The separation was achieved by LC- 20 AT C18 (250mm x 4.6 mm x 2.6 μm) column and Buffer (pH 5.0): Methanol (50:50) as mobile phase, at a flow rate of 1ml/min. Detection was carried out at 220nm. Retention time of Mefenamic acid and Hyoscine Butylbromide were found to be 3.960min and 6.883 min, respectively. The method has been validated for linearity, accuracy and precision. Linearity observed for Hyoscine Butylbromide 2.5-7.5μg/ml and for Mefenamic acid 10-30μg/ml. Developed method was found to be accurate, precise and rapid for simultaneous estimation of Hyoscine Butylbromide and Mefenamic acid In Their Combined Dosage Form. The drug was subjected to stress condition of hydrolysis, oxidation, photolysis and Thermal degradation, Considerable Degradation was found in alkaline degradation. The proposed method was successfully applied for the simultaneous estimation of both the drugs in commercial Combined dosage form.

Keywords: Hyoscine Butylbromide, Mefenamic acid, Stability indicating RP-HPLC Method, Validation.