通过选择性碎片离子 (m/z 135.1) 在人体血中验证LC-MS/MS方法来定量Vibegron:解决矩阵干扰和样本不稳定性
Ashim Kumar Sen1, Santosh Tawari2, Ujashkumar Shah2
1Sumandeep Vidyapeeth Deemed to be University, Vadodara, Gujarat, India.
Biomedical chromatography : BMC
|January 26, 2026
概括
一种新的LC-MS/MS方法准确地量化了vibegron在人体血中的含量. 这种经过验证的测定方法适用于药理动力学和生物等价性研究.
科学领域:
- 分析化学 分析化学
- 药理动力学 药理动力学
背景情况:
- 维贝格龙是一种治疗剂,需要精确量化.
- 在临床研究中,对生物矩阵中精确测量vibegron至关重要.
研究的目的:
- 开发和验证一种灵敏和强大的液体染色学-并联质谱法 (LC-MS/MS) 方法,用于量化人体血中的vibegron.
主要方法:
- 使用正模式的电喷气电离和多重反应监测 (MRM) 的LC-MS/MS分析.
- 采用了一个稳定的同位素标记的内部标准 (vibegron13C5)
- 用乙酸乙烯进行液体-液体提取,并为样品制备添加化.
主要成果:
- 该方法使用100μL等离子体实现了极好的线性 (0.500-400.223 ng/mL),精度 (0.58%-3.34%) 和准确性 (98.26%-102.29%).
- 为了提高选择性,使用了一种新的MRM过渡 (m/z 445.5 → 135.1).
- 该试验表明持续恢复 (87.7%) 并完全符合ICH M10指南.
结论:
- 开发的LC-MS/MS方法是敏感的,强大的,适合量化vibegron在人体血.
- 这种经过验证的方法可以支持未来对vibegron的药理动力学,生物可用性和生物等价性研究.
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