计算机辅助性HPLC方法开发的可能性和局限性,用于基于多糖的性静止阶段的ozanimod
Elek Ferencz1, Zoltán-István Szabó1,2, Arnold Zöldhegyi3
1George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Targu Mures, Târgu Mureş, Romania.
Scientific reports
|November 5, 2024
概括
一种新的HPLC方法使用Chiralpak AD列和极性有机模式准确地确定了ozanimod反体的纯度. 这种方法为免疫调节药物提供了高效的奇拉分离.
科学领域:
- 分析化学 分析化学
- 药品分析 药品分析
背景情况:
- 奥萨尼莫德是一种免疫调节药物,需要精确的对抗体纯度的确定.
- 高性能液体色谱 (HPLC) 对于制药质量控制至关重要.
研究的目的:
- 开发和验证一种直接的HPLC方法来确定ozanimod.com的等离子纯度.
- 以优化使用基于多糖体的柱子和极性有机化来优化奇拉分离.
主要方法:
- 系统方法开发,包括风险评估和参数优化.
- 在极地有机模式下选八个基于多糖的性柱.
- 软件辅助优化 (DryLab) 移动相组成,温度和流量.
主要成果:
- 一个Chiralpak AD列与甲醇:2-propanol:diethylamine移动相实现了基线分离.
- 优化条件:10°C,0.8毫升/分钟流量,70:30:0.1 (v/v/v %) 移动阶段.
- 方法验证和in silico强度测试证实了可靠性.
结论:
- 成功开发了一种强大的和经过验证的直接HPLC方法来测定ozanimod的反体纯度.
- 演示了DryLab软件在极性有机模式下优化奇拉分离的实用性.
相关概念视频
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