在人体血中同时量化菲尔戈提尼布及其活性代谢物,使用液体染色学-并联质谱:验证和临床应用
Takahiro Ito1, Manabu Suno1, Minae Shintani1
1School of Pharmaceutical Sciences, Wakayama Medical University, Wakayama, Japan.
Biomedical chromatography : BMC
|February 19, 2025
概括
一种新的液体色谱-并联质谱法允许在患者血中同时量化菲尔戈提尼布 (FLG) 和其活性代谢物GS-829845. 这种经过验证的方法支持对类风湿性关节炎患者的治疗药物监测.
科学领域:
- 药理学 药理学是指药理学的学科.
- 分析化学 分析化学
- 临床化学 临床化学
背景情况:
- 菲尔戈提尼布 (FLG) 是一种用于治疗炎症症的Janus激酶1抑制剂.
- FLG被代谢成一个活性代谢物,GS-829845.5.
- 目前还没有确立的方法可以在临床样本中同时量化FLG和GS-829845.
研究的目的:
- 开发和验证人类血中FLG和GS-829845的同时定量方法.
- 为了使FLG治疗的患者能够进行治疗药物监测 (TDM).
主要方法:
- 液体染色学-并联质谱法 (LC-MS/MS) 用于同时测定.
- 用甲醇进行简单的脱蛋白化,用于样品制备 (50μL血).
- 染色学分离使用C18柱与水/甲醇移动相和梯度化;通过QTRAP 4500质谱仪的阳性ESI检测.
主要成果:
- 该方法已被验证为FLG (2.5-50 ng/mL) 和GS-829845 (250-5000 ng/mL).
- 测试准确度和精度处于可接受的范围内 (一天内≤11.4%,一天内≤13.9%).
- 观察到一致的恢复和可重现的矩阵效应.
结论:
- 成功开发了一种简单,快速,具有成本效益和完全验证的LC-MS/MS方法,用于同时在人体血中量化FLG和GS-829845.
- 该方法适用于类风湿性关节炎患者的治疗药物监测.
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