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通过质谱技术识别和对林格利平的降解产物的结构性表征

Aleksandra Liana^1,2, Adam Hałuszczuk³, Andrzej Gawor¹

¹Biological and Chemical Research Centre, Faculty of Chemistry, University of Warsaw, Żwirki i Wigury 101, 02-089 Warsaw, Poland.

International journal of molecular sciences

|March 13, 2024

概括

利纳格利普丁的纯度对于药物的质量至关重要. 强制降解研究表明,在酸性和过氧化条件下,利纳格利平是不稳定的,突出了关键的杂质风险.

科学领域:

制药化学制药化学制药化学
分析化学分析化学
药物开发药物开发

背景情况:

活性药物成分 (API) 的纯度对于药物的质量,安全性和有效性至关重要.
在整个制药制造过程中,杂质可以来自各种来源.
了解API降解对于确保治疗有效性和患者安全至关重要.

研究的目的:

为了执行linagliptin的强制降解,以确定潜在的杂质.
为了研究在各种压力条件下对林格利普丁的稳定性概况.
根据国际协调理事会的指导方针,根据国际协调理事会的指导方针,对利纳格利普丁降解产品进行表征.

主要方法:

强制降解研究在酸性,性,氧化,热性和光解条件下进行.
使用照片阵列探测器 (UPLC-PAD) 的超高性能液态色谱用于分析降解概况.
使用液态染色体质谱法 (LC-MS) 技术,包括高分辨率质谱法 (HRMS),识别和表征了降解产品.

主要成果:

在酸性水解和氧化应激条件下,林格利普丁表现出显著的降解.
在性水解,热应力或光解条件下没有观察到实质性降解.
几种linagliptin的降解产物成功地被识别和表征.

结论:

林格利平特特别容易受到酸和过氧化物诱导的降解.
这些发现提供了关键的洞察力,对linagliptin的稳定性和潜在的杂质形成.
这项研究支持开发强大的制造工艺和质量控制策略,以linagliptin为基础的药品.

关键词:

这就是LC-PDA-MS.在LC-Q-ToF-MS中使用.降解降解降解降解降解.降解特征的降解特征杂质的识别杂质的识别林纳利普丁 (linagliptin) 的使用情况

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