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Updated: Mar 1, 2026

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超敏感的HPLC-ESI-MS/MS测量含有烯酸的抗感冒产品中的N-尼特罗斯-烯酸

Pál T Szabó¹, András Darcsi², Gábor Turczel³

¹MS Metabolomics Research Laboratory, Centre for Structural Science, HUN-REN Research Centre for Natural Sciences, Magyar tudósok krt 2, Budapest H-1117, Hungary; National Drug Research and Development Laboratory, HUN-REN Research Centre for Natural Sciences, Magyar tudósok krt 2, Budapest H-1117, Hungary.

Journal of pharmaceutical and biomedical analysis

|February 28, 2026

概括

一种新的分析方法检测了N-nitroso-phenylephrine (NNPE),一种致癌杂质,在普通感冒药物中. 该方法在所有测试产品中发现了NNPE,其中一些超出了安全限值,突出了制药质量控制的必要性.

科学领域:

药品分析药品分析
分析化学分析化学
药品安全药品安全

背景情况:

烯是一种常见感冒药物的成分,可以形成N-nitroso-phenylephrine (NNPE),一种潜在的致癌性尼托胺.
药品中酸胺污染日益令人担忧,但NNPE缺乏特定的方法.

研究的目的:

开发和验证一种敏感和选择性的分析方法,用于量化基基感冒药中的NNPE.
评估NNPE在商业制药产品中的流行率和水平.

主要方法:

开发一种高性能液体染色学-电子喷射电离-并联质谱法 (HPLC-ESI-MS/MS) 方法.
方法验证根据ICH Q2(R2) 准则,包括线性,准确性,精度和低检测极限 (1.95 pg/mL) 和定量 (3.9 pg/mL).
简单的样品制备,涉及直接水溶和使用同位素标记的内部标准进行分析,以减轻矩阵效应.

主要成果:

经过验证的HPLC-ESI-MS/MS方法证明了NNPE确定高灵敏度,选择性和可靠性.
在所有分析的含的商业抗感冒产品中检测到NNPE.
一些产品含有NNPE含量超过了确定的可接受摄入量限制.

结论:

开发的方法适用于常规质量控制和含的药品的安全性评估.
这些发现表明需要监测感冒药中的NNPE污染.
确保药品安全需要强大的分析工具来检测潜在的有害杂质,如NNPE.

关键词:

抗寒产品抗寒产品抗寒产品在HPLCMS/MS/MS中使用.方法验证方法的验证方法.尼特罗斯烯 (N-nitroso-phenylephrine) 是一种含有N-nitroso-phenylephrine的化合物.亚胺酸盐的含量是多少制药杂质制药杂质是药品中的杂质.基氨酸 (Phenylephrine) 是一种基氨酸.

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