通过CZE对治疗性的定量分析,在水力动力学上封闭的分离系统中使用多个样本注射
Ondrej Stefanik1,2, Peter Mikus1,2, Juraj Piestansky2,3,4
1Department of Pharmaceutical Analysis and Nuclear Pharmacy, Faculty of Pharmacy, Comenius University in Bratislava, Bratislava, Slovakia.
Electrophoresis
|May 13, 2024
概括
开发了新的毛细管电泳方法来分析治疗性酸triptorelin和lanreotide. 这些方法为质量控制和临床应用提供了高效率和准确性.
科学领域:
- 分析化学 分析化学
- 制药科学 制药科学
背景情况:
- 治疗性,如triptorelin和lanreotide在现代医学中至关重要.
- 开发精确的分析方法对于其质量控制和临床使用至关重要.
研究的目的:
- 开发和验证新的毛细血管电泳 (CE) 方法来确定三素和兰类.
- 建立第一个基于CE的方法用于lanreotide和第一个用于triptorelin的水力动力学封闭系统 (HCS) CE方法.
主要方法:
- 在具有紫外线检测的水力动力学封闭系统 (HCS) 中进行毛细管区电泳 (CE).
- 重复注射样品的引入技术.
- 使用酸和甲基-基乙烯纤维素优化背景电解质.
主要成果:
- 达到最大的分离效率和信号强度.
- 证明了出色的校准曲线 (r2>0.99),低检测极限 (0.25-0.5μg/mL),可接受的精度和准确性.
- 在药物配方和的尿样中成功量化了triptorelin.
结论:
- 开发的CE方法在分析托雷林和兰胺方面非常高效,准确和精确.
- 这些方法在治疗性的质量控制和临床研究中具有卓越的适用性.
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