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ICP-MS方法用于同时确定人体白蛋白输液溶液中的,和

Sena Ozlem Gundogdu¹, Yeliz Aytimur¹, Seda Turhan¹

¹Department of R&D, Centurion Pharma, Ankara, Türkiye.

International journal of analytical chemistry

|February 28, 2025

概括

开发了一种使用ICP质谱法 (ICP-MS) 的新方法,可以同时检测人体白蛋白溶液中的,和,通过满足元素杂质的药典限制来确保患者的安全.

科学领域:

分析化学分析化学
药品分析药品分析
微量元素分析微量元素分析

背景情况:

药品中的元素杂质可能会影响患者的健康和安全.
人类白蛋白溶液是一种关键的亲肠道药物,欧洲药典对 (K), (Al) 和 (Na) 规定了限制.
像ICP-AAS和ICP-OES这样的现有方法无法在药库限制内同时分析这三个元素.

研究的目的:

开发和验证一种用于人类白蛋白溶液中同时定量确定K,Al和Na的新方法.
建立一个可靠的分析技术,满足基本杂质测试的药典要求.

主要方法:

利用感应合等离子体质谱法 (ICP-MS) 进行同时元素分析.
通过检测极限 (LOD),特异性,线性,可重复性和准确性评估来评估方法性能.
计算的回收百分比,以验证该方法的定量准确性.

主要成果:

达到了Na (0.0105767μg/mL),K (0.001748μg/mL) 和Al (2.0568E-4μg/mL) 的低检测极限.
证明了出色的线性,Na和K的回归系数为0.999,Al的回归系数为0.995.
报告了高的重复性恢复率 (Na为98.70%,K为98.38%,Al为90.83%) 和各种度水平 (50%,100%,150%) 的准确结果.

结论:

成功开发并验证了一种ICP-MS方法,用于在人体白蛋白溶液中同时量化K,Al和Na.
经过验证的方法提供了一种可靠和有效的方法,以确保符合制药产品元素杂质限值.
这一进步提高了人体白蛋白溶液的质量控制,有助于提高患者安全.

关键词:

在ICP-MS中,使用的是ICP-MS.合金合金的使用情况.人类白蛋白溶液输液.和是一种酸盐的使用方法验证验证的时间

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