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<p>Ethylene glycol and diethylene glycol are toxic compounds detected in medicinal products (especially in cough syrups and solutions) due to violations of manufacturing technology or falsification. Their organoleptic similarity to glycerol and propylene glycol makes detection impossible without physicochemical analysis. The aim of the present study was to develop and validate a method for the quantitative determination of ethylene glycol and diethylene glycol in solutions and syrups using gas chromatography with mass spectrometric detection (GC-MS). The use of a flame ionization detector (GC-FID) with a complex syrup matrix was associated with the risk of superposition of signals of target analytes on signals of matrix components, which reduced the reliability of the results. The proposed GC-MS method had high selectivity and sensitivity, which made it a universal screening procedure regardless of the complexity of the matrix. The method was validated according to GPC 1.1.0012 for the parameters specificity, linearity, accuracy, precision, sensitivity, and stability.</p>

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Development and Validation of a Gas-Chromatography–Mass-Spectrometry Method for Quantitative Determination of Ethylene Glycol and Diethylene Glycol in Solutions for Internal Use and Cough Syrups

  • 期刊论文

  • 发表日期：

    2025年11月1日

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  • N. A. Lezhnina,
  • A. L. Khokhlov,
  • N. A. Sidel’nikov,
  • R. R. Galeev,
  • D. V. Somov,
  • I. A. Basalaeva

摘要

Ethylene glycol and diethylene glycol are toxic compounds detected in medicinal products (especially in cough syrups and solutions) due to violations of manufacturing technology or falsification. Their organoleptic similarity to glycerol and propylene glycol makes detection impossible without physicochemical analysis. The aim of the present study was to develop and validate a method for the quantitative determination of ethylene glycol and diethylene glycol in solutions and syrups using gas chromatography with mass spectrometric detection (GC-MS). The use of a flame ionization detector (GC-FID) with a complex syrup matrix was associated with the risk of superposition of signals of target analytes on signals of matrix components, which reduced the reliability of the results. The proposed GC-MS method had high selectivity and sensitivity, which made it a universal screening procedure regardless of the complexity of the matrix. The method was validated according to GPC 1.1.0012 for the parameters specificity, linearity, accuracy, precision, sensitivity, and stability.