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<p>A green and stability indicating high-performance thin-layer chromatography (HPTLC) method was developed and validated for the estimation of desidustat in bulk and tablet formulations using Analytical Quality by Design (AQbD) principles. The method was optimized using a Box-Behnken Design (BBD), considering mobile phase volume, chamber saturation time, and solvent front as critical parameters. The optimized mobile phase—toluene:ethyl acetate:methanol:formic acid (10.5:3:1.5:0.45, v/v/v/v)—yielded a sharp and well-resolved separation at Rf 0.45 ± 0.02. The method was validated as per ICH Q2(R2) guideline confirmed excellent linearity (600–1600&#xa0;ng/band, r<sup>2</sup> = 0.997), accuracy (98.84–101.87%), precision (RSD &lt; 2%), and robustness. The drug was found most susceptible to acidic degradation where a distinct degradation product was resolved, confirming the method’s stability indicating nature. The method exhibited good sensitivity (LOD: 220.8&#xa0;ng/band; LOQ: 517.9&#xa0;ng/band) and specificity without interference from excipients or degradation products. Greenness was evaluated using AGREE and ComplexGAPI tools, with an AGREE score of 0.87, confirming its environmentally sustainable profile. This study present the first AQbD driven and environmentally sustainable HPTLC method for desidustat, establishing a robust framework that offers a validated, stability-indicating, and eco-friendly approach suitable for routine pharmaceutical quality control.</p> Graphical Abstract <p></p>

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Integration of analytical quality by design and green chemistry principles in the development of an HPTLC method for Desidustat estimation

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年3月16日

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  • Parmar Bharvi,
  • Bhavin Thummar,
  • Bhumika Dudhatra,
  • Hardi Joshi,
  • Bhumika Maheriya,
  • Jigna Vadalia,
  • Kashyap Thummar

摘要

A green and stability indicating high-performance thin-layer chromatography (HPTLC) method was developed and validated for the estimation of desidustat in bulk and tablet formulations using Analytical Quality by Design (AQbD) principles. The method was optimized using a Box-Behnken Design (BBD), considering mobile phase volume, chamber saturation time, and solvent front as critical parameters. The optimized mobile phase—toluene:ethyl acetate:methanol:formic acid (10.5:3:1.5:0.45, v/v/v/v)—yielded a sharp and well-resolved separation at Rf 0.45 ± 0.02. The method was validated as per ICH Q2(R2) guideline confirmed excellent linearity (600–1600 ng/band, r2 = 0.997), accuracy (98.84–101.87%), precision (RSD < 2%), and robustness. The drug was found most susceptible to acidic degradation where a distinct degradation product was resolved, confirming the method’s stability indicating nature. The method exhibited good sensitivity (LOD: 220.8 ng/band; LOQ: 517.9 ng/band) and specificity without interference from excipients or degradation products. Greenness was evaluated using AGREE and ComplexGAPI tools, with an AGREE score of 0.87, confirming its environmentally sustainable profile. This study present the first AQbD driven and environmentally sustainable HPTLC method for desidustat, establishing a robust framework that offers a validated, stability-indicating, and eco-friendly approach suitable for routine pharmaceutical quality control.

Graphical Abstract