<p>Topiroxostat (TPX) is a xanthine oxidoreductase inhibitor used in the treatment of gout. For the determination of TPX in bulk and tablets, four simple, specific, precise, sensitive, rapid, and eco-friendly, parallel UV-Visible spectrophotometry methods were developed. Although UV-Visible spectrophotometry estimation work is based on zero-order and first-order derivative spectral transformation, these methods also relied on absorbance, amplitude, and area under the curve of the UV-spectrum. TPX exhibited linearity in the concentration range of 2–12 μg/mL in all four methods, with a correlation coefficient of r<sup>2</sup> &gt; 0.99. The estimated percentage of drug in the developed methods was found to be in good agreement with what the label claim for the Topimac® tablet formulation. Each method was validated in accordance with the International Council for Harmonisation (ICH) Q2(R2) guidelines. All of these developed methods were linear, accurate, precise, and adequately sensitive, and they were evaluated using one-way ANOVA to assess the statistical comparison of the results. The analyses indicated that the F-value was found to be less than the critical P-value, and there was no identifiable variability in the outcomes. This implied that, for all four methods, there were no significant statistical differences between the results, indicating that they are the best parallel and multimode approaches for the estimation of TPX.</p>

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Parallel and Multimode UV-Visible Spectrophotometry Investigations for Topiroxostat

  • Pooja Barkule,
  • Amod S. Patil,
  • Atul A. Shirkhedkar,
  • Saurabh B. Ganorkar,
  • Suraj R. Chaudhari

摘要

Topiroxostat (TPX) is a xanthine oxidoreductase inhibitor used in the treatment of gout. For the determination of TPX in bulk and tablets, four simple, specific, precise, sensitive, rapid, and eco-friendly, parallel UV-Visible spectrophotometry methods were developed. Although UV-Visible spectrophotometry estimation work is based on zero-order and first-order derivative spectral transformation, these methods also relied on absorbance, amplitude, and area under the curve of the UV-spectrum. TPX exhibited linearity in the concentration range of 2–12 μg/mL in all four methods, with a correlation coefficient of r2 > 0.99. The estimated percentage of drug in the developed methods was found to be in good agreement with what the label claim for the Topimac® tablet formulation. Each method was validated in accordance with the International Council for Harmonisation (ICH) Q2(R2) guidelines. All of these developed methods were linear, accurate, precise, and adequately sensitive, and they were evaluated using one-way ANOVA to assess the statistical comparison of the results. The analyses indicated that the F-value was found to be less than the critical P-value, and there was no identifiable variability in the outcomes. This implied that, for all four methods, there were no significant statistical differences between the results, indicating that they are the best parallel and multimode approaches for the estimation of TPX.