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Updated: Jul 17, 2025

Untargeted Metabolomics from Biological Sources Using Ultraperformance Liquid Chromatography-High Resolution Mass Spectrometry UPLC-HRMS

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Published on: May 20, 2013

用LC-MS-QTOF与H/D交换和NMR进行对Vorinostat稳定性行为的批判性评估

Naveen Chandrasekar¹, Kalyani Sharma¹, Sonali Jain¹

¹Department of Pharmaceutical Analysis, National Institute of Pharmaceutical Education and Research (NIPER), Ahmedabad, India.

Journal of pharmaceutical and biomedical analysis

|September 1, 2023

概括

伏利诺斯塔特是一种HDAC抑制剂,对酸性和性条件敏感,但在热和光解应激下稳定. 鉴定了降解产品,并发现它们具有与Vorinostat相似的安全性.

科学领域:

制药化学制药化学制药化学
药物稳定性研究药物稳定性研究
分析化学分析化学

背景情况:

沃里诺斯塔特是一种美国FDA批准的HDAC抑制剂,用于皮肤T细胞淋巴瘤.
了解药物降解对于配方开发和确保患者安全至关重要.

研究的目的:

为了研究Vorinostat在各种压力条件下的降解行为.
开发和验证Vorinostat的稳定性指示分析方法.
为了识别和描述沃里诺斯塔特降解剂,并评估其在中的毒性.

主要方法:

强制降解研究 (水解,氧化,热,光解) 的Vorinostat.
开发和验证一种稳定性指示液态染色学 (LC) 方法.
使用LC-高分辨率质谱法 (LC-HRMS),MS/MS和-交换质量研究进行降解剂的表征.
已识别的降解剂的体内毒性预测.

主要成果:

沃里诺斯塔特对酸性和性环境非常敏感.
药物物质在热和光解应力下稳定在固体形式.
鉴定和描述了六种主要的降解剂.
降解剂通过在中毒性评估显示出与Vorinostat相似的安全概况.

结论:

沃里诺斯塔特的稳定性取决于pH值,在酸性和基本条件下更大的不稳定性.
开发的LC方法适用于监测沃里诺斯塔的纯度和降解.
鉴定到的降解剂不构成重大安全问题,允许对规范限值制定一般杂质指导方针.

关键词:

强制降解产品的强制降解产品在的毒性.这就是LC-MS-QTOF.压力研究研究研究压力.这就是Vorinostat.

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