通过ICP-MS和微波消化来开发和验证罗斯瓦斯塔丁片中元素不洁物的分析程序
Yajie Hao1, Guang Yin1, Xuemei Wang1
1National Engineering Research Center of Chiral Drugs, Lunan Pharmaceutical Group, 1 North Outer Ring Road, Fei, Linyi, Shandong, China.
Journal of analytical methods in chemistry
|April 3, 2024
概括
使用ICP-MS的新方法准确地测量了罗斯瓦斯塔丁片中的元素杂质. 这种经过验证的技术通过检测Cd,Pb和Hg等有毒元素来确保药物安全.
科学领域:
- 分析化学 分析化学
- 药品分析 药品分析
背景情况:
- 罗斯瓦斯塔丁是一种治疗失脂症的关键药物.
- 控制药品中的元素杂质对于患者的安全至关重要.
- 现有的方法可能会在复杂的矩阵上扎,例如罗苏瓦斯塔丁片中的复杂矩阵.
研究的目的:
- 开发和验证一种可靠的分析方法,用于确定罗苏瓦斯塔丁片中的元素杂质.
- 为制药产品中元素杂质制定有效的控制策略.
主要方法:
- 一种新的消化技术与感应合血质谱法 (ICP-MS) 结合使用.
- 该方法被优化为与动能歧视 (KED) 的碰撞电池模式.
- 具体元素 (Cd,Pb,As,Hg,Co,V,Ni) 使用内部标准 (Bi,In,Y) 进行量化.
主要成果:
- 该方法表现出色,在量化极限时的回收率从90.5%到106.4%不等.
- 实现了高线性 (相关系数>0.9997),准确性 (91.8%103.6%) 和精度 (RSD ≤1.8%).
- 消化方法有效地处理了具有挑战性的辅助剂,包括二氧化.
结论:
- 开发的ICP-MS方法是敏感的,有选择性的,准确的,用于量化罗斯瓦斯塔丁中的元素杂质.
- 这种经过验证的方法提供了一种可靠的工具,用于质量控制和确保罗斯瓦斯塔丁药物的安全性.
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