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在临床应用中使用高性能液体染色学-双重质谱法同时确定奥西默蒂尼布及其代谢物

Jingjing Wu¹, Liuxian Guo^1,2, Guojin Zhou³

¹Department of Pharmacy, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China.

Therapeutic drug monitoring

|August 26, 2025

概括

一种新的HPLC-MS/MS方法准确地测量了osimertinib及其活性代谢物. 患者的特征如性别和BMI与代谢物水平相关,有助于个性化治疗.

科学领域:

药理学和毒理学
分析化学
癌症学

背景情况:

奥西默蒂尼布是非小细胞肺癌 (NSCLC) 的第一线治疗方法.
AZ5104和AZ7550是奥西默提尼布的强效活性代谢物.
了解它们的药理动力学对于优化NSCLC治疗至关重要.

研究的目的:

开发和验证一种敏感的分析方法,用于在人体血中同时量化奥西默蒂尼布及其活性代谢物 (AZ5104,AZ7550).
将验证的方法应用于NSCLC患者的临床样本.
探索代谢物度与患者基线特征之间的相关性.

主要方法:

使用高性能液体染色学-双重质谱法 (HPLC-MS/MS).
血样本经过蛋白质沉.
通过在正态下使用电喷离子进行量化,并进行多重反应监测.

主要成果:

该方法在特定范围的 osimertinib,AZ7550 和AZ5104 中显示出极好的线性.
准确性和精度在可接受的验证标准范围内 (在±15%和<15%CV范围内).
该方法已成功应用于临床NSCLC患者样本.

结论:

经过验证的HPLC-MS/ MS方法适用于在NSCLC患者的血中分析奥西默蒂尼布及其代谢物.
在女性中,AZ7550的平衡状态最低度显著更高.
身体质量指数与AZ5104和AZ7550的稳定状态最低度相关.

关键词:

在HPLCMS/MS 皮肤生长因子受体类激酶抑制剂非小细胞肺癌奥西默蒂尼布治疗药物监测

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