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<p>Capecitabine is a prodrug converted to its only active metabolite, 5-fluorouracil (5-FU), by thymidine phosphorylase. Formulations of capecitabine, such as nanocarriers and microspheres, are being developed for the treatment of breast and colorectal cancers to enhance therapeutic efficacy and improve patient compliance. The objective of this research work is to quantitatively determine capecitabine using the analytical quality by design (AQbD) methodology principle to estimate capecitabine via a Box–Behnken statistical design (BBD). Three distinct factors and three corresponding levels (mobile phase, flow rate, and injection volume) of BBD are used for method optimization and analysis of capecitabine in tablet dosage form. A rapid, highly reliable, effortless, and effective high-performance liquid chromatographic method has been developed and validated. The analysis is conducted using a Shimadzu C18 column through an isocratic elution methodology, with the mobile phase consisting of 80:20% (v/v) ethanol and water. The flow rate is set to 1.5&#xa0;mL/min, with an injection volume of 10 µL and at a detection wavelength of 241&#xa0;nm. Changes in the mobile phase ratio and flow rate affect the results, but the injection volume has a minimal impact. The methodology’s distinctiveness lies in its sustainable analytical framework. The developed approach demonstrated excellent greenness. The methods of greenness were expressed by the pictograms of NEMI, Modified NEMI, GAPI, Complex GAPI, AGREE, and AGREEprep, as well as the analytical eco-score value of 93 based on the greenness assessment tools. Therefore, the green method, based on the AQbD approach and validation results, is appropriate for routine analysis of capecitabine in pharmaceutical dosage forms in quality control laboratories.</p> Graphical Abstract <p></p>

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AQbD-Based Green Analytical Techniques for the Determination of Capecitabine Using Box–Behnken Design for Optimization of an Eco-friendly RP-HPLC Method

  • 期刊论文

  • 发表日期：

    2025年9月19日

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  • Roshni Kunte,
  • Prafulla Sabale,
  • Komal Somkuwar,
  • Vaibhav Sawale,
  • Vidya Sabale

摘要

Capecitabine is a prodrug converted to its only active metabolite, 5-fluorouracil (5-FU), by thymidine phosphorylase. Formulations of capecitabine, such as nanocarriers and microspheres, are being developed for the treatment of breast and colorectal cancers to enhance therapeutic efficacy and improve patient compliance. The objective of this research work is to quantitatively determine capecitabine using the analytical quality by design (AQbD) methodology principle to estimate capecitabine via a Box–Behnken statistical design (BBD). Three distinct factors and three corresponding levels (mobile phase, flow rate, and injection volume) of BBD are used for method optimization and analysis of capecitabine in tablet dosage form. A rapid, highly reliable, effortless, and effective high-performance liquid chromatographic method has been developed and validated. The analysis is conducted using a Shimadzu C18 column through an isocratic elution methodology, with the mobile phase consisting of 80:20% (v/v) ethanol and water. The flow rate is set to 1.5 mL/min, with an injection volume of 10 µL and at a detection wavelength of 241 nm. Changes in the mobile phase ratio and flow rate affect the results, but the injection volume has a minimal impact. The methodology’s distinctiveness lies in its sustainable analytical framework. The developed approach demonstrated excellent greenness. The methods of greenness were expressed by the pictograms of NEMI, Modified NEMI, GAPI, Complex GAPI, AGREE, and AGREEprep, as well as the analytical eco-score value of 93 based on the greenness assessment tools. Therefore, the green method, based on the AQbD approach and validation results, is appropriate for routine analysis of capecitabine in pharmaceutical dosage forms in quality control laboratories.

Graphical Abstract