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基拉LC-MS/MS方法用于在基于皇冠的基拉静止相上对三甲氨酸酶体进行区分

Byeongchan Choi¹, Suraj Adhikari^2,3, Moong-Gi Ji¹

¹College of Pharmacy, Sunchon National University, Suncheon, South Korea.

|July 19, 2023

概括

一种新的LC-MS/MS方法可以有效地分离D/L-triiodothyronine (T3) 类反体. 这种经过验证的方法准确地量化了T3化学品和liothyronine片中的反体杂质.

科学领域:

分析化学分析化学
药品分析药品分析
螺旋式分离螺旋式分离

背景情况:

三iodothyronine (T3) 是一种关键的甲状腺激素,具有重要的药物和临床相关性.
对于质量控制和治疗疗效来说,T3的反体分离是必不可少的.

研究的目的:

开发和验证一种有效的选方法,用于分离D/L-T3体.
为了量化商业T3化学品和制药产品中的反体杂质.

主要方法:

使用液体染色学-双重质谱法 (LC-MS/MS) 采用基于皇冠的奇拉静止相.
优化分析条件,并采用精选反应监测 (SRM) 进行敏感检测.
验证了可行性,准确性,反选择性和灵敏性的方法.

主要成果:

在10分钟内实现了D/L-T3反体的基线分离.
已建立的检测极限为D-T3的0.05 ng/μl,L-T3的0.20 ng/μl,L-T3的0.10 ng/μl,L-T3的0.50 ng/μl).
在商业T3化学品和liothyronine片中检测到0.11%至6.57%的反体杂质.

结论:

开发的LC-MS/MS方法是准确的,敏感的,并且对T3反体的分离具有反选择性.
该方法适用于检测药品T3配方中的反体杂质.
在商业T3产品中确定了不同程度的反体杂质,突出了严格的质量控制的必要性.

关键词:

十八冠六四碳酸十八冠六四碳酸.这是LC-MS/MS.性静止阶段静止阶段体分离的分离方法三胺氨酸的三胺氨酸.

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