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<p>A novel HPTLC method was designed and validated for the simultaneous quantification of Aceclofenac and Febuxostat, a newer pharmaceutical combination. The method incorporates green analytical chemistry principles. Chromatographic separation was performed on pre-coated silica gel 60 F<sub>254</sub> plates. Wavelength, chamber saturation time, volume of ethyl acetate, and solvent front were studied critically and optimized. Robustness was assessed by applying 2<sup>4–1</sup> fractional factorial design. The greenness of the method was assessed using four tools: Analytical Eco-scale, Blue Applicability Grade Index, Complementary Green Analytical Procedure Index, and Analytical Greenness Metric Approach. Further, RGB tool was used to assess the whiteness of the method. The optimized mobile phase (ethyl acetate: toluene: glacial acetic acid, 7:3:0.1) provided sharp peaks at R<sub>f</sub> 0.47 and 0.71, respectively. Linearity was observed between 150 and 900&#xa0;ng/band for Aceclofenac and 100–600&#xa0;ng/band for Febuxostat, with correlation co-efficients of 0.9931 and 0.9788. The method was precise (%RSD &lt; 2 %), accurate (92.7–96.9 % recovery), and robust (DoE-based fractional factorial design showed non-significant variation). Greenness was confirmed using Eco-Scale (84), AGREE (0.8), and BAGI tools. The method is simple, economical, and suitable for routine quality control of Febuxostat and Aceclofenac in topical formulations. The developed HPTLC method is efficient, precise, and adheres to green analytical chemistry principles. It provides a reliable and environmentally friendly approach for the simultaneous quantification of Aceclofenac and Febuxostat in ufasomal gel.</p>

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An eco-friendly HPTLC approach for the estimation of febuxostat and aceclofenac in ufasomal gel

  • 期刊论文

  • 发表日期：

    2025年10月10日

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  • Khyati S. Parekh,
  • Vaishali Thakkar,
  • Chetan Sojitra,
  • Devang Tandel,
  • Kalpana G. Patel

摘要

A novel HPTLC method was designed and validated for the simultaneous quantification of Aceclofenac and Febuxostat, a newer pharmaceutical combination. The method incorporates green analytical chemistry principles. Chromatographic separation was performed on pre-coated silica gel 60 F254 plates. Wavelength, chamber saturation time, volume of ethyl acetate, and solvent front were studied critically and optimized. Robustness was assessed by applying 24–1 fractional factorial design. The greenness of the method was assessed using four tools: Analytical Eco-scale, Blue Applicability Grade Index, Complementary Green Analytical Procedure Index, and Analytical Greenness Metric Approach. Further, RGB tool was used to assess the whiteness of the method. The optimized mobile phase (ethyl acetate: toluene: glacial acetic acid, 7:3:0.1) provided sharp peaks at Rf 0.47 and 0.71, respectively. Linearity was observed between 150 and 900 ng/band for Aceclofenac and 100–600 ng/band for Febuxostat, with correlation co-efficients of 0.9931 and 0.9788. The method was precise (%RSD < 2 %), accurate (92.7–96.9 % recovery), and robust (DoE-based fractional factorial design showed non-significant variation). Greenness was confirmed using Eco-Scale (84), AGREE (0.8), and BAGI tools. The method is simple, economical, and suitable for routine quality control of Febuxostat and Aceclofenac in topical formulations. The developed HPTLC method is efficient, precise, and adheres to green analytical chemistry principles. It provides a reliable and environmentally friendly approach for the simultaneous quantification of Aceclofenac and Febuxostat in ufasomal gel.