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<p>Lactose intolerance is common, so accurate detection of lactose in supplements and pharmaceuticals is critical. We validated an ultra-high performance liquid chromatography–tandem mass spectrometry (U-HPLC–MS/MS) method with high sensitivity and specificity for trace lactose in products labeled “lactose-free.” The workflow mitigates matrix effects through solid-phase extraction and filtration and explicitly accounts for α/β mutarotation to ensure correct identification and quantification. Validation per ISO and ICH Q2 confirmed robustness and performance superior to enzymatic/colorimetric assays for quality control and regulatory compliance. The method achieved excellent linearity (<i>R</i><sup>2</sup> &gt; 0.995) over 0.05–10&#xa0;ppm, recoveries of 95–105%, precision with RSD &lt; 2%, LOQ 0.05&#xa0;ppm, and matrix effect &lt; 15%. These results enable reliable verification of “lactose-free” claims across diverse matrices, reducing false positives, enhancing reproducibility, and improving labeling transparency.</p>

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Analytical validation of an advanced U-HPLC–MS/MS method for lactose detection in food supplements and pharmaceuticals

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年2月2日

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  • Alessandro Nencioni,
  • Kristian Comelli,
  • Michela Bulfoni,
  • Emanuele Nencioni

摘要

Lactose intolerance is common, so accurate detection of lactose in supplements and pharmaceuticals is critical. We validated an ultra-high performance liquid chromatography–tandem mass spectrometry (U-HPLC–MS/MS) method with high sensitivity and specificity for trace lactose in products labeled “lactose-free.” The workflow mitigates matrix effects through solid-phase extraction and filtration and explicitly accounts for α/β mutarotation to ensure correct identification and quantification. Validation per ISO and ICH Q2 confirmed robustness and performance superior to enzymatic/colorimetric assays for quality control and regulatory compliance. The method achieved excellent linearity (R2 > 0.995) over 0.05–10 ppm, recoveries of 95–105%, precision with RSD < 2%, LOQ 0.05 ppm, and matrix effect < 15%. These results enable reliable verification of “lactose-free” claims across diverse matrices, reducing false positives, enhancing reproducibility, and improving labeling transparency.