Abstract

ESTABLISHMENT AND VALIDATION OF SPECTROPHOTOMETRIC METHOD FOR THE ANALYSIS AND QUANTIFICATION OF MIRABEGRON AND SOLIFENACIN IN TABLET DOSAGE FORMS BY ABSORPTION RATIO METHOD

Alexlivingston M. Nadar*, Snehalatha Boddu, Ashwin S. Nainapatruni, Pinky A. Rajbhar

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Abstract

The current method development was intended for the determination and quantification of Mirabegron and Solifenacin from a tablet dosage form by using Absorption Ratio Method of UV-Visible Spectroscopic method. Methanol was found to be an appropriate solvent as both the drugs were highly soluble in it, after which the recording of the absorbance was carried out at wavelength maxima(λmax) at 248.8nm and 221.2nm, respectively. The obtained curve was then analysed using Shimadzu Software for determination of Isosbestic pint and we found that Mirabegron and Solifenacin showed same absorbances at 222.6nm i.e., Isosbestic point. Calibration curve was plotted for both the drugs with concentration range of 3-15μg/mL. The plot exhibited a perfect linear relationship for both the drugs with Regression coefficient R²= 0.9996 and R²= 0.9999, respectively. The method was found to fulfil all the validation parameters according to ICH guidelines. The method showed good robustness and reproducibility and can be used for the estimation of these drugs from Tablet forms.

Keywords: Mirabegron, Solifenacin, Absorption Ratio Method, ICH Guidelines.