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一种替代方法验证液体染色学-质谱法用于内源化合物的量化方法的验证方法

Martin Uher¹, Stanislav Mičuda², Marian Kacerovský³

¹Department of Medical Biochemistry, Faculty of Medicine in Hradec Králové, Charles University, Šimkova 870, Hradec Králové 500 03, Czech Republic.

Journal of chromatography. A

|July 1, 2023

概括

这项研究引入了一种用于验证内源性物质分析试验的新方法,克服了它们在生物样本中自然存在所带来的挑战. 这种方法确保了代谢学研究的准确量化,包括诊断与怀孕相关的肝病.

科学领域:

分析化学分析化学
生物化学生物化学
临床诊断临床诊断临床诊断

背景情况:

在生物矩阵中量化内源性物质是具有挑战性的,因为没有空白样本.
现有的方法,如代用矩阵或分析物枯竭矩阵可能不可靠或昂贵.
开发内源性化合物的精确分析方法需要创新的样品制备技术.

研究的目的:

开发一种替代的,具有成本效益的方法,用于为内源性物质准备验证参考样本.
为了应对生物矩阵中固有的分析物存在的挑战.
确保临床和代谢应用的分析方法的可靠性和准确性.

主要方法:

采用了经过修改的标准加法方法,结合了来自聚合生物样本的基底度测量.
使用真实的分析标准来准备验证参考样本,保持生物矩阵的完整性.
液体染色学-双重质谱法 (LC-MS/MS) 用于分析人体血中的15种胆酸.

主要成果:

根据欧洲药物局 (EMA) 的指导方针,开发的方法已成功验证.
达到了5nmol/L的下限量化和胆酸的线性从5到2000nmol/L.
该方法在代谢学研究中显示出有效性,有助于确认孕妇肝脏内胆固醇形成的情况.

结论:

拟议的方法为准备内源性物质的验证参考样本提供了可靠和高效的替代方案.
这种方法提高了分析方法的准确性,特别是在代谢学和临床诊断方面.
经过验证的方法在识别和管理与怀孕相关的肝脏疾病方面具有实际应用.

关键词:

其他替代验证方法胆汁酸胆汁酸是一种这是LC-MS/MS.

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