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用于绿色和可持续的药品质量控制的微芯片异:方法验证和应用于复杂的药物配方的方法验证

Marta Ďuriš¹, Jasna Hradski¹, Roman Szucs¹

¹Department of Analytical Chemistry, Faculty of Natural Sciences, Comenius University Bratislava, Ilkovičova 6, Bratislava SK-84215, Slovakia.

Journal of chromatography. A

|June 9, 2024

概括

新的万能微芯片异位电泳 (μITP) 方法为心血管药物提供快速,准确和环保的分析. 这些经过验证的方法精确地确定了各种配方中的活性药物成分和对应物.

科学领域:

分析化学分析化学
药品分析药品分析
绿色化学绿色化学

背景情况:

心血管药物通常以盐的形式销售,因此需要精确确定活性药物成分 (API) 和对应成分.
现有的分析方法可能涉及大量的样品准备,高试剂消耗和较长的分析时间.

研究的目的:

开发通用微芯片异位电泳 (μITP) 方法,用于分析盐形式心血管药物的阴离子和阴离子成分.
根据国际协调理事会 (ICH) 的指导方针验证这些方法.
评估开发的μITP方法对环境的影响 (绿色).

主要方法:

开发通用微芯片异位电泳 (μITP) 技术.
应用内部标准的补充,以提高定量准确性.
验证方法的线性,精度,准确性和特异性.
使用AGREE (化学工艺绿色度评估) 工具对方法绿色度的评估.

主要成果:

开发的μITP方法在矩阵存在和缺席条件下都显示出高线性 (相关系数≥0.9993).
在分析物确定方面,获得了卓越的精度 (相对标准偏差<1.5%) 和准确性 (恢复率98102%).
这些方法已成功应用于量化六种商业心血管药物配方中的宏观成分.

结论:

普遍的μITP方法为盐形式的心血管药物提供了快速,精确和准确的分析解决方案.
开发的方法显示了样品和试剂消耗的减少,浪费最小,能源需求低,与绿色化学原则保持一致.
这些经过验证的μITP技术适用于药物配方的常规质量控制和分析.

关键词:

药品中的活性药物成分.其他国家和地区.绿色分析化学绿色分析化学微芯片是同太极光电的.制药分析制药分析

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