影响选择稳定同位素标记内部标准 (SIL-ISs) 的洞察力,用于LC-MS/MS定量测定
Nuggehally R Srinivas1, Raja Reddy Kallem1, Michael G Bartlett2
1Department of Clinical Pharmacology and Pharmacometrics, Lundbeck Pharmaceuticals LLC, Deerfield, Illinois, USA.
Biomedical chromatography : BMC
|October 10, 2025
概括
准确的药理动力学分析依赖于经过验证的试验和适当的稳定同位素标记的内部标准 (SIL-IS). 然而,SIL-IS可以引起交叉信号干扰,导致液体染色学-并联质谱法 (LC-MS/MS) 方法的测试偏差.
科学领域:
- 药理学和制药科学 药理学和制药科学
- 分析化学 分析化学
- 生物技术是生物技术.
背景情况:
- 经过验证的生物分析测定对于药物开发过程中准确的药理动力学 (PK) 报告至关重要.
- 稳定同位素标记的内部标准 (SIL-IS) 常用于液体染色学-并联质谱学 (LC-MS/MS) 进行明确的分析量化.
- 选择具有足够质量差的SIL-IS是测试开发中的一个关键考虑因素.
研究的目的:
- 审查与SIL-IS在生物分析试验中的使用相关的潜在问题.
- 为管理交叉信号贡献和测试偏差提供见解.
- 提高对LC-MS/MS方法开发中的SIL-IS挑战的理解.
主要方法:
- 文献综述和对SIL-IS现有知识的综合.
- 分析交叉信号干扰的潜在来源.
- 对标准曲线线性和试验偏差的影响的讨论.
主要成果:
- 来自SIL-IS的交叉信号贡献可能来自各种因素,影响量化.
- 标准曲线的非线性和测试偏差的增加是SIL-IS问题的潜在后果.
- 了解这些问题对于可靠的生物分析数据至关重要.
结论:
- 需要仔细选择和验证SIL-IS以减轻潜在的问题.
- 解决与SIL-IS相关的挑战可以提高药理动力学研究的准确性和可靠性.
- 这一观点旨在指导研究人员在测试开发过程中管理SIL-IS复杂性.
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