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分析验证一种先进的U-HPLC-MS/MS方法,用于检测食品补充剂和药品中的乳糖

Alessandro Nencioni¹, Kristian Comelli², Michela Bulfoni³

¹IBSA Institut Biochimique SA, Via del Piano, 29, CH-6915, Pambio Noranco, Switzerland.

Analytical and bioanalytical chemistry

|February 2, 2026

概括

准确检测补充剂中的微量乳糖至关重要. 一种经过验证的超高性能液态色谱-并联质谱法 (U-HPLC-MS/MS) 方法为"无乳糖"产品的验证提供了高灵敏度和特异性.

科学领域:

分析化学分析化学
制药科学制药科学
食品科学食品科学食品科学

背景情况:

乳糖不耐症影响全球人口的很大一部分.
药品和补充剂中乳糖的准确量化对于消费者安全和监管合规性至关重要.
现有的乳糖检测方法可能缺乏复杂矩阵中微量检测所需的灵敏度或特异性.

研究的目的:

验证一种高度敏感和特定的超高性能液体染色学-并联质谱法 (U-HPLC-MS/MS) 方法来检测微量乳糖.
为了确保精确的乳糖识别和量化,考虑到α/β突变.
提供可靠的方法来验证补充剂和药品中的"无乳糖"声明.

主要方法:

采用了超高性能液体染色学-并联质谱法 (U-HPLC-MS/MS).
使用固体相提取 (SPE) 和过来减轻矩阵效应.
该方法在分析过程中明确考虑了乳糖α/β突变.
根据ISO和ICH Q2指南进行了验证.

主要成果:

在U-HPLC-MS/MS方法证明了优秀的线性 (R2>0.995) 从0.05-10ppm.
实现了高恢复率 (95-105%) 和精度 (RSD <2%).
证实了0.05ppm的低量化极限 (LOQ) 和最小的矩阵效应 (<15%).
性能优于酶性/色度测定试验.

结论:

经过验证的U-HPLC-MS/MS方法提供了微量乳糖的敏感,特定和可重复检测.
这种方法可以可靠地验证"无乳糖"的说法,提高标签透明度,减少假阳性.
该方法支持强有力的质量控制和对药品和补充剂产品的监管合规性.

关键词:

过敏原过敏原过敏原食补充剂食补充剂食补充剂标准 ISO 标准 ISO 标准 ISO 标准乳糖是一种乳糖.方法验证方法的验证方法.质量控制质量控制在U-HPLCMS/MS技术上.

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