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提高药物安全性和减轻健康问题:在levothyroxine案例研究中的高分辨率质谱学

Hana Chmelařová¹, Maria Carmen Catapano¹, Jean-Christophe Garrigues²

¹Department of Analytical Chemistry, Faculty of Pharmacy in Hradec Králové, Charles University, Akademika Heyrovského 1203, 500 05, Hradec Králové, Czech Republic.

Journal of pharmaceutical analysis

|October 1, 2024

概括

调查levothyroxine配方发现了意想不到的化学变化和未申报的成分. 这凸显了超越当前药品质量控制的先进分析方法的需要.

科学领域:

制药科学制药科学
分析化学分析化学
药物的配方药物的配方

背景情况:

利沃甲氧氨酸具有狭窄的治疗指数,使得配方变化至关重要.
与levothyroxine配方相关的不良药物反应需要科学解释.
目前的药品质量控制可能无法完全捕捉配方的复杂性.

研究的目的:

通过非向的分析方法来研究levothyroxine配方.
为了识别不同类别的甲基产品中的化学变化和意想不到的成分.
评估当前制药质量控制机制的充分性.

主要方法:

使用超高性能液态色谱与数据独立采集高分辨率质谱学 (UHPLC-DIA-HRMS) 相结合.
在全面的配方分析中采用非有针对性的分析策略.
专注于检测降解产品和意外的辅助剂相关化合物.

主要成果:

鉴定了levothyroxine降解产物和辅助剂相关化合物,包括曼尼托尔反应产物.
在多种配方中检测到levothyroxine-lactose附加物和未申报的脂.
证明存在意想不到的化合物,这些化合物通常不会受到标准质量控制的覆盖.

结论:

非向的UHPLC-DIA-HRMS对于详细的制药配方分析是有效的.
利沃甲素配方可能含有未申报和意想不到的化学实体.
目前的药品质量控制可能不足以确保配方完整性和患者安全.

关键词:

药物安全药物安全辅助物质辅助物质辅助物质杂质是指不纯净的东西.利沃甲氧氨酸 (Levothyroxine) 是一种药物.在UHPLC-DIA-HRMS中使用.

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