通过通过扩大化合物数据库和图书馆来对高性能液态染色学充电的气溶检测和成分的表征来对聚合物酸盐20进行歧视
Shi-Qi Wang1,2, Xun Zhao1, Li-Jun Zhang1,2
1Jiangsu Institute for Food and Drug Control, Nanjing, 210019, China.
Journal of pharmaceutical analysis
|May 27, 2024
概括
这项研究开发了一种高分辨率的方法来分析聚酸盐20 (PS20) 的成分,揭示了PS20等级和来源之间的显著差异. 这些发现提高了对PS20成分的理解,以提高药物安全性和有效性.
科学领域:
- 分析化学 分析化学
- 制药科学 制药科学
- 生物化学 生物化学
背景情况:
- 聚二酸盐20 (PS20) 组成分析是复杂的,因为类似的成分结构,影响药物配方和患者安全.
- 在PS20的起源和等级的变化需要强大的分析方法来准确的表征.
研究的目的:
- 开发和验证用于分离和识别PS20组件的高分辨率定量方法.
- 调查来自不同来源和等级的PS20的组成差异.
- 评估降解对PS20组件的影响.
主要方法:
- 具有充电气溶检测 (CAD) 的单维高性能液态色谱 (HPLC) 用于分离和量化.
- 超高性能液态染色学-四极飞行时间质谱 (UHPLC-Q-TOF-MS) 用于组件识别.
- 扩展聚酸盐化合物数据库和图书馆.
主要成果:
- 18个关键PS20组件的分离和表征.
- 在不同的PS20批次中使用UHPLC-Q-TOF-MS.识别1329到1511种化合物.
- 在四种降解条件下观察PS20组件变化.
- 对区分PS20批量和准产品的指纹差异的洞察力.
结论:
- 开发的HPLC-CAD和UHPLC-Q-TOF-MS方法可以进行全面的PS20分析.
- 从不同来源和等级的PS20中存在显著的组成变化.
- 该方法提供了评估组合-过程关系和确保药物产品质量的关键数据.
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