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开发一种绿色高性能液体染色法,用于药物配方中的托法西提尼布量化和降解研究

Gizem Tiris¹, Asena Ayse Genc^2,3, Nevin Erk²

¹Department of Analytical Chemistry, Faculty of Pharmacy, Bezmialem Vakif University, Istanbul, Turkey.

Biomedical chromatography : BMC

|April 2, 2024

概括

一种新的高性能液体染色学 (HPLC) 方法准确量化托法西替尼. 这种经过验证,具有成本效益和环保的技术为实验室和生物等价性研究提供了快速分析.

科学领域:

分析化学分析化学
药品分析药品分析

背景情况:

托法西提尼布是一种用于治疗自身免疫性疾病的Janus激酶抑制剂.
准确量化药物活性成分对于药物开发和质量控制至关重要.

研究的目的:

开发和验证一种新的高性能液体染色学 (HPLC) 方法,用于精确量化托法西提尼布.
评估方法的效率,成本效益和环境影响.

主要方法:

使用Chromasil 100 C18列对托法西提尼布的量化.
移动阶段:乙二:0.2%的酸在水中 (12:88,v/v).
在285.0nm处检测,流速0.8mL/min,温度40.0°C,运行时间5.0分钟.

主要成果:

该方法在10.0-200.0μg/mL范围内证明了线性.
恢复值在97.66%至105.68%之间.
开发的HPLC方法是根据ICH指南进行验证的.

结论:

成功开发了一种快速,具有成本效益和环保的HPLC方法来定量托法西提尼布.
经过验证的方法适用于例行实验室分析和生物等价性研究.

关键词:

在HPLC中使用HPLC.确定性确定性确定性绿色的绿色的绿色的绿色.托法西提尼布 (tofacitinib) 是一种验证验证的时间

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