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Xiaodong Yang¹, Minmin Tu¹, Chunlan Tang²

¹Reference Laboratory, Medical System Biotechnology Co., Ltd., Ningbo, Zhejiang, China.

Journal of mass spectrometry : JMS

|August 20, 2025

概括

使用同位素稀释液体染色学- 双重质谱的新候选参考测量程序 (cRMP) 准确地量化了人体血中的克洛扎 (CLO). 这种经过验证的方法增强了治疗药物监测 (TDM) 以提高患者的安全性和临床结果.

科学领域:

分析化学
临床化学
药理学

背景情况:

对于有效的治疗药物监测 (TDM) 来说,精确量化克洛扎 (CLO) 在人体血中至关重要.
现有的方法可能缺乏可靠的CLO测量所需的特异性和准确性.
需要开发一个候选参考测量程序 (cRMP) 来标准化CLO量化.

研究的目的:

开发和验证用于精确量化人类血中的克洛扎的候选参考测量方法 (cRMP).
建立一种可靠的方法来标准化CLO的治疗药物监测 (TDM).
通过精确的CLO水平测定来改善临床结果和患者安全.

主要方法:

开发了一种使用同位素稀释液体染色学-双重质谱 (ID-LC-MS/MS) 的候选参考测量程序.
系统优化染色分离和评估 clozapine 的样本预处理方法.
严格验证分析性能,包括特异性,回收,精度,线性,LOQ,LOD,转移,稳定性和方法比较,根据GUM评估测量不确定性.

主要成果:

在广泛的度范围 (5.65-1693.51 ng/g) 中,ID-LC-MS/MS方法显示出极好的线性 (R2 = 0.9988).
实现高精度,总变化系数 (CVs) 低至0.65%,平均回收率在97.80%至99.28%之间.
该方法表现出2.73 ng/g的低量化极限 (LoQ) 和0.91 ng/g的检测极限 (LoD),具有明确的测量不确定性.

结论:

开发的cRMP满足了基准测量程序的所有标准,并显示出出色的特异性,准确性,精度和可追溯性.
这种经过验证的ID-LC-MS/MS方法提供了一个可靠的工具来准确地测量人体血中的克洛扎.
已建立的cRMP有可能标准化克洛扎的治疗药物监测 (TDM),最终提高患者的安全性和临床管理.

关键词:

ID-LCMS/MS 其他分析性能克洛萨平测量不确定性治疗药物监测可追溯性

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