在多孔石墨碳静止相上的线性溶剂强度模型,使用高温液态色谱方法对所有普林醇相关物质进行分析
Barnabás Soós1, Krisztián Horváth2, Róbert Kormány1
1Drug Substance Analytical Development Division, Egis Pharmaceuticals PLC, Keresztúri út 30-38, Budapest H-1106, Hungary.
概括
使用多孔石墨碳 (PGC) 柱的新型高性能液态染色学 (HPLC) 方法有效地分析阿洛普醇及其杂质. 线性溶剂强度 (LSS) 理论准确地模拟了保留,使药物分析的快速方法优化成为可能.
科学领域:
- 分析化学 分析化学
- 染色体学 染色体学 是一种染色学.
背景情况:
- 高性能液态染色学 (HPLC) 对于制药分析至关重要.
- 多孔石墨碳 (PGC) 静止相具有独特的分离能力.
- 开发有效的Allopurinol及其杂质的方法对于质量控制至关重要.
研究的目的:
- 开发和优化阿洛普醇及其欧洲药典 (Ph.Eur.) 的HPLC方法. 杂质,杂质,杂质,杂质.
- 为了研究Allopurinol和杂质在PGC静止相上的保留行为.
- 评估线性溶剂强度 (LSS) 理论在PGC阶段的方法开发中的适用性.
主要方法:
- 开发一种使用PGC静止相的HPLC方法.
- 在温度范围 (30-90°C) 和梯度时间 (5-20分钟) 中研究溶液保留.
- 线性溶剂强度 (LSS) 理论和色谱建模软件的应用,以优化方法.
主要成果:
- 在逆相和PGC相之间观察到明显的保留机制.
- 在LSS理论中,有效地模拟了Allopurinol及其杂质在PGC阶段的保留.
- 在优化的条件下 (pH 2.0,6分钟梯度时间,60°C) 在6分钟内实现了所有溶液的基线分辨率.
结论:
- 线性溶剂强度 (LSS) 理论适用于开发基于PGC的HPLC系统的分析方法.
- 开发的HPLC方法提供了有效和快速的分析Allopurinol及其Ph.Eur. 杂质,杂质,杂质,杂质.
- 该研究为PGC阶段方法开发提供了适用于制药分析的一般框架.
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