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<p>The growing demand for eco-friendly and cost-effective analytical methods has driven the development of a fast, green, and sensitive GC-MS assay for the simultaneous quantification of paracetamol (PAR) and metoclopramide (MET) in pharmaceutical formulations and human plasma. Separation was achieved in 5&#xa0;min using a high-polarity 5% Phenyl Methyl Silox column, with detection at *m/z* 109 (PAR) and 86 (MET). The method was fully validated per ICH guidelines, showing excellent linearity (PAR: 0.2–80&#xa0;µg/mL, r² = 0.9999; MET: 0.3–90&#xa0;µg/mL, r² = 0.9988) and precision (tablet recovery: 102.87 ± 3.605% PAR, 101.98 ± 3.392% MET; plasma recovery: 92.79 ± 1.521% PAR, 91.99 ± 2.153% MET). Greenness assessment via three metrics, including the BAGI tool (score: 82.5), confirmed its environmental superiority over conventional methods. With high sensitivity, accuracy, and a 5-minute runtime, this approach is ideal for routine quality control and pharmacokinetic studies.</p>

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BAGI-assessed green GC-MS method for rapid analysis of paracetamol/metoclopramide in pharmaceuticals and plasma

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年11月18日

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  • Lateefa A. Al-Khateeb,
  • Mohammed Gamal,
  • Mohamed A. Elsayed,
  • Raimar Löbenberg,
  • Amira M. Hegazy

摘要

The growing demand for eco-friendly and cost-effective analytical methods has driven the development of a fast, green, and sensitive GC-MS assay for the simultaneous quantification of paracetamol (PAR) and metoclopramide (MET) in pharmaceutical formulations and human plasma. Separation was achieved in 5 min using a high-polarity 5% Phenyl Methyl Silox column, with detection at *m/z* 109 (PAR) and 86 (MET). The method was fully validated per ICH guidelines, showing excellent linearity (PAR: 0.2–80 µg/mL, r² = 0.9999; MET: 0.3–90 µg/mL, r² = 0.9988) and precision (tablet recovery: 102.87 ± 3.605% PAR, 101.98 ± 3.392% MET; plasma recovery: 92.79 ± 1.521% PAR, 91.99 ± 2.153% MET). Greenness assessment via three metrics, including the BAGI tool (score: 82.5), confirmed its environmental superiority over conventional methods. With high sensitivity, accuracy, and a 5-minute runtime, this approach is ideal for routine quality control and pharmacokinetic studies.