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一种新的绿色HS/SPME-GC/NPD方法,用于选和定量固体样本中的氨酸:适用于洛萨坦片

Amanda Tavares Germano¹, Gustavo Amadeu Micke¹, Luciano Vitali¹

¹Department of Chemistry, Federal University of Santa Catarina, State of Santa Catarina, 88035-972, Brazil.

|July 3, 2025

概括

使用HS/SPME-GC/NPD的新方法直接分析洛萨坦片中的氨酸 (NA). 这种绿色,低成本的方法有效地检测到NAs,其中两片超过了NDEA限制.

科学领域:

药品分析药品分析
分析化学分析化学
绿色化学绿色化学

背景情况:

药品中的氨酸 (NA) 对患者的健康构成重大风险.
确保药品质量需要强大的分析方法来检测NA.
目前的方法可能不适合直接分析固体样本.

研究的目的:

开发和验证洛萨坦片中六种尼托拉胺的直接分析方法.
为质量控制提供一个绿色,具有成本效益的选和量化工具.
评估该方法对其他固体制药样品的适用性.

主要方法:

头部空间固相微提取 (HS/SPME) 使用DVB/汽车/PDMS光纤.
用-检测 (GC/NPD) 的气相色谱.
优化的提取条件:4片,250rpm动,85分钟,45°C.

主要成果:

使用矩阵匹配校准的高确定系数 (>0.99).
低检测极限 (0.00010.0157毫克每公斤-1).
恢复率 (79.7122.0%) 和精度 (<18.7%) 证实了方法的有效性.
在分析的13片药片中,有2片超出了NDEA的监管限制.

结论:

开发的HS/SPME-GC/NPD方法具有选择性,敏感性和有效性,用于量化洛萨坦片中的突变性尼托拉胺.
该方法符合绿色化学原理,由AGREE计算器证实.
这种方法适用于质量控制,可以应用于其他固体药物形式.

关键词:

气体染色学是一种气体染色学.矩阵匹配校准匹配的校准.检测的检测方法尼托胺是一种氨酸.选方法选方法固相微提取固相微提取方法

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