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Updated: May 25, 2025

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在使用HPLC-ICP-MS的四度基Gd基对比剂中量化Gd物种

Sonja Weishaupt¹, Wiebke Holkenjans², Sandra Balzer²

¹University of Münster, Institute of Inorganic and Analytical Chemistry, Corrensstr. 48, 48149 Münster, Germany.

Journal of chromatography. A

|February 25, 2025

概括

一种新的HPLC-ICP-MS方法准确地量化了MRI对比剂 (GBCA) 中的加多 (Gd) 复合物. 这种敏感的技术可以检测到微量副产品,有助于制药开发和质量控制.

科学领域:

分析化学分析化学
药理学药理学是指药理学的学科.
放射化学放射化学是指辐射化学.

背景情况:

基于加多的对比剂 (GBCA) 在磁共振成像 (MRI) 中至关重要.
确保GBCA的纯度,比如四重体宏环剂Gadoquatrane,对于患者的安全和药物的有效性至关重要.
复杂GBCA的合成可以导致各种含有Gd的副产品,需要精确量化.

研究的目的:

开发和验证一种敏感的分析方法,用于在GBCAs中量化Gd复合体.
建立一种能够检测和量化多核Gd复合物和其他Gadoquatrane中的副产品的方法.
为制药品质量控制提供强大的替代方法,比如HPLC-UV等现有方法.

主要方法:

开发了高性能液体染色学-感应合等离子体质谱法 (HPLC-ICP-MS).
该方法使用外部校准与通用Gd标准进行准确量化.
该技术用于分析早期工艺开发中的Gadoquatrane样本.

主要成果:

在HPLC-ICP-MS方法证明高灵敏度和准确性Gd复杂量化.
在Gadoquatrane样本中检测到六种不同的多重体含Gd的副产品.
单体Gd复合物的量化极限 (LOQ) 为38nmol/L,使得检测率低至0.004质量%.

结论:

开发的HPLC-ICP-MS方法是评估微量GBCA中未知的含Gd的副产品的强大工具.
这种方法有助于优化合成过程和制定药物物质控制策略.
在不合成参考化合物的情况下量化副产品的能力加快了制药开发时间表.

关键词:

在HPLC-ICP-MS中使用.带连线的技术带连线的技术基于Gd的MRI对比剂Multimeric Gd是一种基于MRI的对比剂.对Gd复合物的量化.规格分析规格分析

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