开发一个逆相HPLC方法,用于在聚合物微粒中同时测定黄素和甲
Dana Haj-Ali1, Hanan Azzam2, Khaled Aiedeh1
1Faculty of Pharmacy, The University of Jordan, Amman, Jordan.
Future science OA
|October 27, 2025
概括
一种新的RP-HPLC方法准确地量化了纳米粒子药物递送系统中的黄素和甲. 这种经过验证的方法有助于对这些先进配方的质量控制和优化.
科学领域:
- 制药科学 制药科学
- 分析化学 分析化学
- 纳米技术纳米技术
背景情况:
- 聚合物微粒纳米粒子提供了先进的药物递送潜力.
- 同时量化活性药物成分对于配方开发至关重要.
- 黄素和甲是具有明显特性的关键治疗剂.
研究的目的:
- 开发和验证一种快速,简单,准确和强大的RP-HPLC方法,用于同时量化黄素和甲.
- 在聚合物微粒纳米粒子中应用评估这些药物的封装效率的方法.
主要方法:
- 逆相高性能液态色谱 (RP-HPLC) 使用通用HS C18列.
- 用甲醇进行异离子化:酸水 (pH3.5,80:20,v/v) 移动阶段.
- 库尔库明在425nm和德克萨米在254nm的检测,根据ICH指南进行验证.
主要成果:
- 实现了优异的线性 (R2 > 0.999),精度 (RSD% < 2%) 和精度 (98.7-101.7%的恢复).
- 低检测限值 (0.0035毫克/毫升对于黄素,0.0029毫克/毫升对于德克萨米他) 和量化.
- 在Soluplus®/DOPE纳米颗粒中,对黄素 (78.84 ± 0.05%) 和甲 (54.33 ± 0.05%) 的高封装效率 (EE%).
结论:
- 开发的RP-HPLC方法适用于同时测定黄素和甲.
- 这种方法促进了聚合物微粒纳米粒子药物递送系统的质量控制和优化.
- 能够对药物负载和配方性能进行可靠的评估.
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