在药品中的N-尼胺定量通过并联质谱法
Mousumi Saha1, Lingqi Qiu1, Stefan Kraft2
1Department of Chemistry, Purdue University, West Lafayette, Indiana 47907, United States.
Analytical chemistry
|September 22, 2025
概括
一种新的多重反应监测 (MRM) 方法可以快速量化药品中的N-尼托拉胺杂质的痕量. 这种方法利用 adduct 形成进行敏感检测,帮助药物安全和质量控制.
科学领域:
- 药品分析 药品分析
- 分析化学 分析化学
- 质谱测量质量谱测量
背景情况:
- N-尼托胺是致变性杂质,在药品中构成重大风险.
- 它们的存在导致了药物召回,增加了监管审查.
- 同时快速分析多种N-尼托胺是一种持续的分析挑战.
研究的目的:
- 开发一种快速而强大的分析方法来量化多种N-尼托胺.
- 为了在各种制药矩阵中实现微量检测N-尼托胺.
- 为制药品质量控制提供一个实用的工具.
主要方法:
- 开发一种多重反应监测 (MRM) 方法,使用双重质谱法 (MS/MS).
- 利用酸 (Li+) adduct 形成,以增强电离和碎片化.
- 验证了在广泛的度范围内 (10 ng/mg到500 μg/mg) 量化微量水平的方法.
主要成果:
- 每个样品的快速分析时间不到1分钟.
- 证明检测极限低至5ng/mg,具有高准确度和精度.
- 成功应用了在制药矩阵中量化N-化药物杂质的方法.
结论:
- 开发的MRM方法为N-尼托胺分析提供了快速,稳健和灵敏的解决方案.
- 最小的样品制备和广泛的适用性使其适用于复杂的配方.
- 这种方法是制药质量控制和工业环境的宝贵工具.
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