应用先进的高分辨率质谱技术来分析洛萨坦的已知和未知的杂质
Laura Backer1, Helmut Buschmann2, Martina Kinzig3
1University of Würzburg, Institute for Pharmacy and Food Chemistry, 97074 Würzburg, Germany.
Journal of pharmaceutical and biomedical analysis
|January 10, 2024
概括
由于意想不到的杂质而导致的药物召回,比如洛萨坦中的阿齐多杂质,可以减轻. 这项研究强调了一种综合分析方法来检测新杂质,确保患者安全和药物质量.
科学领域:
- 药品分析 药品分析
- 分析化学 分析化学
- 药品质量控制 药品质量控制
背景情况:
- 药品召回往往是由于意外的杂质造成的,这些杂质会给健康带来风险.
- 洛萨尔坦含有酸杂质的污染说明了需要强大的分析方法的需要.
- 检测和控制杂质对于患者安全和供应链稳定至关重要.
研究的目的:
- 开发和应用一种结合的非目标和目标分析策略,用于识别药物中的未知杂质.
- 评估高分辨率质谱在杂质分析中的能力.
- 在洛萨坦样本中调查已知和未知的杂质.
主要方法:
- 使用Zorbax RR StableBond C18柱与梯度化和电子喷雾电离.
- 在一般未知的比较分析中采用非定向选方法.
- 使用提取的离子染色体和依赖信息的获取应用有针对性的数据评估.
- 通过增值证实了N-甲基-2-pyrrolidone (NMP) 的身份,并通过标准添加估计了其数量.
主要成果:
- 通过非目标查确定了N-甲基-2-pyrrolidone (NMP) 和另一种与合成相关的杂质.
- 通过对质谱数据的有针对性的评估,发现了四种额外的杂质.
- 证明了组合分析方法在检测以前未描述的杂质方面的有效性.
- 在六个研究的洛沙坦样本中突出显示了杂质的存在.
结论:
- 结合非向和向的高分辨率质谱方法对于早期检测药物质量变化至关重要.
- 这种方法提高了识别和控制新杂质的能力,提高了药物安全性.
- 积极检测杂质对于防止供应瓶和确保治疗疗效至关重要.
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