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<p>This research work involves developing a liquid chromatographic method to estimate Related substances of Afatinib in drug products Method optimization was done by employing Box-Behnken design, one of the Analytical Quality-by-design approaches. The developed and validated stability indicating liquid chromatographic method is deemed to be eco-friendly or green based on its evaluation results obtained by greenness assessment tools. Afatinib along with three known impurities showed adequate resolution on the Zodiac C<sub>18</sub> (150 × 4.6&#xa0;mm, 3&#xa0;μm) column, maintained at 42º C within 20&#xa0;min. The mobile phase composition involves mobile phase- A (pH 6.0 ammonium acetate buffer with the aid of ion pair reagent) and mobile phase-B (ethanol: water, in the ratio of 90: 10% V/V), pumped at a flow rate of 0.65 mL/min by gradient elution mode. The % total impurity is found to be 0.08, 9.68, 5.40, 0.077, 0.07 in acid, base, peroxide, thermal and photolytic treated samples. LOD and LOQ for Afatinib and impurities are found to be 0.06 ppm and 0.2 ppm respectively. Based on the obtained validation results, it is found that the optimized method is specific (stability indicating), linear, accurate, precise and robust. The proposed HPLC method is found to be green method based on obtained analytical eco-scale score and pictograms of greenness assessment tools. The eco-friendly liquid chromatographic method provides an effective means to evaluate and quantify Afatinib related impurities in tablets dosage form, minimizing harm to the environment and living beings.</p>

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AQbD assisted green HPLC method for quantification of Afatinib impurities in drug products

  • 期刊论文

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  • 发表日期：

    2026年3月25日

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  • Pankaj Kisan Chatki,
  • Ujwala N. Mahajan

摘要

This research work involves developing a liquid chromatographic method to estimate Related substances of Afatinib in drug products Method optimization was done by employing Box-Behnken design, one of the Analytical Quality-by-design approaches. The developed and validated stability indicating liquid chromatographic method is deemed to be eco-friendly or green based on its evaluation results obtained by greenness assessment tools. Afatinib along with three known impurities showed adequate resolution on the Zodiac C18 (150 × 4.6 mm, 3 μm) column, maintained at 42º C within 20 min. The mobile phase composition involves mobile phase- A (pH 6.0 ammonium acetate buffer with the aid of ion pair reagent) and mobile phase-B (ethanol: water, in the ratio of 90: 10% V/V), pumped at a flow rate of 0.65 mL/min by gradient elution mode. The % total impurity is found to be 0.08, 9.68, 5.40, 0.077, 0.07 in acid, base, peroxide, thermal and photolytic treated samples. LOD and LOQ for Afatinib and impurities are found to be 0.06 ppm and 0.2 ppm respectively. Based on the obtained validation results, it is found that the optimized method is specific (stability indicating), linear, accurate, precise and robust. The proposed HPLC method is found to be green method based on obtained analytical eco-scale score and pictograms of greenness assessment tools. The eco-friendly liquid chromatographic method provides an effective means to evaluate and quantify Afatinib related impurities in tablets dosage form, minimizing harm to the environment and living beings.