有效的HPLC-ELSD分析和在aripiprazole延长释放注射 суспензия使用三模柱技术的三模柱技术
Alexandra Bitziou1,2, Theodora Fotiou2, Constantinos K Zacharis1
1Laboratory of Pharmaceutical Analysis, Department of Pharmacy, Aristotle University of Thessaloniki GR-54124 Greece czacharis@pharm.auth.gr.
RSC advances
|October 30, 2025
概括
这项研究开发了一种新的HPLC-ELSD方法,用于量化药品注射中的和离子. 经过验证的技术为药品中的无机离子分析提供了更简单,更具成本效益的替代方案.
科学领域:
- 分析化学 分析化学
- 药品分析 药品分析
背景情况:
- 准确量化和等无机离子对于制药配方的一致性和安全性至关重要.
- 现有的无机离子分析方法可能很复杂或昂贵.
研究的目的:
- 开发和验证一种强大的和有选择性的高性能液态染色学 (HPLC) 方法与蒸发光散射探测器 (ELSD) 相结合.
- 为了使和离子在aripiprazole延长释放注射悬浮中的同时确定.
- 为传统方法 (如离子染色学或ICP-MS) 提供成本效益和简单的替代方案.
主要方法:
- 使用了三模静止相柱,结合了逆相,阴离子交换和离子交换机制.
- 使用HPLC与ELSD相结合,用于敏感检测非染色体无机离子.
- 根据国际协调理事会 (ICH) 的指导方针验证了该方法.
主要成果:
- 达到高线性 (R2>0.99),可接受的精度 (RSD<10%),精度 (95-105%的恢复).
- 已证明适用于常规质量控制的检测极限 (LOD) 值.
- 在分析的药物配方中证实了方法的稳定性.
结论:
- 开发的HPLC-ELSD方法是无机离子分析的强大,有选择性和可重复的工具.
- 这种方法为分析复杂的制药矩阵中的无机离子提供了更简单,更经济的替代方案.
- 该方法适用于药品的常规质量控制.
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