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通过UHPLC-Q-TOF/MS对药物辅助剂聚乙烯甘醇进行多关键质量属性分析的新战略

Yutong Sun¹, Qi Liu¹, Zhe Wang¹

¹State Key Laboratory of Bioactive Substance and Function of Natural Medicines, Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.

Journal of chromatography. A

|January 10, 2025

概括

一种新方法使用UHPLC-Q-TOF/MS来分析聚乙烯糖醇 (PEG) 的关键质量属性. 该策略有效评估用于药品质量控制的PEG组件.

科学领域:

制药科学制药科学
分析化学分析化学
聚合物科学聚合物科学

背景情况:

聚乙烯甘醇 (PEG) 是药品中至关重要的聚合物辅助剂,对于药物配方和输送至关重要.
PEG的关键质量属性 (CQAs) 显著影响其物理化学性质和功能性能.
目前的分析方法在同时评估多个PEG CQAs时缺乏效率.

研究的目的:

开发一种新的,快速和简单的策略,用于同时评估多个PEG CQAs.
建立一个可靠的分析方法,以全面识别和量化PEG成分.
验证有效控制PEG助剂和药品制剂的质量战略.

主要方法:

开发一种超高性能液态色谱技术,并配合四极飞行时间质谱法 (UHPLC-Q-TOF/MS) 方法.
移动相添加剂的优化,以减轻PEG组件的质量歧视效应.
分子特征提取和解卷的应用,用于识别PEG成分,并建立基于保留时间和聚合度的数学模型.

主要成果:

同时评估四个关键的PEG CQAs:聚合的平均程度,平均分子量,重量平均分子量和多分散性.
使用优化的UHPLC-Q-TOF/MS方法在混合物样本中识别168个PEG成分.
构建了220个PEG组件的理论数据库和CQA的验证计算公式,证明了高效率.

结论:

开发的策略为同时分析多个PEG CQAs提供了有效的解决方案.
这种方法可以提高PEG辅助剂和含有PEG的药品的质量控制.
该方法为制药制造和研究中的常规分析提供了高效率和准确性.

关键词:

关键的质量属性是关键的质量属性.大规模歧视效应.制药辅助剂制药辅助剂制药辅助剂聚乙烯糖醇是一种聚乙烯糖醇.在UHPLC-Q-TOF/MS中使用.

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