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在洛萨坦和奥尔梅萨坦药物中测定N-二甲基胺的电压测量方法

Tassio A Nunes¹, Fernanda S Soares¹, João V M Mariz¹

¹Universidade Federal da Paraíba, Departamento de Química, 58051-970 João Pessoa, Paraíba, Brasil.

Journal of pharmaceutical sciences

|January 19, 2025

概括

一种新的分析方法可以在没有预处理的情况下检测萨尔坦药物中的N-二甲基胺 (NDMA). 这种环保的方形波阳极剥离电压测量技术为NDMA分析提供了灵敏和快速的替代方案.

科学领域:

分析化学分析化学
环境化学环境化学

背景情况:

萨尔坦药物已被召回,原因是N-二甲基胺 (NDMA) 污染.
NDMA是一种强有力的致癌物质,因此需要可靠的分析方法来检测它.
目前在药品中检测NDMA的现有方法可能是复杂和耗时的.

研究的目的:

开发一种新的,快速的,环保的分析方法,用于在萨尔坦药物中确定NDMA.
为了验证拟议方法的性能与既有技术相比.
为药品质量控制中的常规NDMA分析提供一个具有成本效益的解决方案.

主要方法:

方波阳极剥离电压测量 (SWASV) 使用添加的钻石电极 (BDDE).
标准添加程序 (SAP) 在没有样本预处理的情况下进行量化.
与高性能液体染色学与二极管阵列检测 (HPLC-DAD) 作为参考方法进行比较.

主要成果:

通过SWASV-BDDE-SAP方法,在2502500 nmol L-1范围内显示出线性反应 (R2 = 0.995).
达到67.6nmol L-1的检测极限 (LOD),具有良好的准确性 (94.3%104.7%) 和可重现性 (SD = 5.6%).
在洛沙坦和奥尔梅沙坦样本中,建议的方法和HPLC-DAD用于NDMA的确定之间没有观察到统计学上显著的差异.

结论:

开发的SWASV-BDDE-SAP方法是一种敏感,可复制和稳定的技术,用于在萨尔坦药物中检测NDMA.
该方法缺乏化学预处理,使其成为环保的替代方案,符合绿色分析化学原则.
这种方法为萨尔坦药物的常规质量控制提供了具有成本效益和快速的解决方案,提高了患者的安全性.

关键词:

抗高血压药物抗高血压药物用添加的钻石电极.这是一种N-二甲基胺 (nitrosodimethylamine).方形波阳极剥离电压计方形波阳极剥离电压计

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