先进的稳定性指示RP-HPLC方法用于定量散装的卢拉西化和基于PLGA的in situ植入物配方
Bankar Anup Ramprasad1, Sundeep Chaurasia2, Indu Singh1
1Amity Institute of Pharmacy, Amity University Uttar Pradesh, Noida, Uttar Pradesh 201301, India.
Annales pharmaceutiques francaises
|November 1, 2024
概括
一种新的稳定性指示RP-HPLC方法已经开发和验证了卢拉西化 (LURA-H) 和其基于PLGA的植入物配方. 该方法精确,准确,适合质量控制分析.
科学领域:
- 分析化学 分析化学
- 制药科学 制药科学
- 材料科学 是一种材料科学.
背景情况:
- 卢拉西二 (LURA-H) 是一种关键的抗精神病药物.
- 基于Poly-D,L乳糖酸 (PLGA) 的实体存储形成植入物提供持续的药物输送.
- 精确量化其配方中的LURA-H对于质量控制至关重要.
研究的目的:
- 开发和验证一个稳定性指示RP-HPLC方法Lurasidone化 (LURA-H).
- 量化LURA-H在其基于PLGA的现场仓库形成植入物 (LURA-H-PLGA-ISI) 中的LURA-H.
- 确保该方法适用于常规质量控制分析.
主要方法:
- 根据ICH指南进行RP-HPLC方法开发和验证.
- 使用了具有发现C18列的Waters 2695系统.
- 在各种应力条件下 (热,光,水解) 进行了力降解研究.
主要成果:
- 实现了对LURA-H和LURA-H-PLGA-ISI的良好色谱分离.
- 证明了线性,准确性 (100±2%) 和精度 (%RSD <2%).
- 该方法被证明是稳固的,灵敏的 (LOD 0.07 μg/mL,LOQ 0.22 μg/mL),在应力条件下稳定.
结论:
- 开发的RP-HPLC方法简单,强大,精确和准确.
- 该方法适用于散装药物和PLGA配方中的LURA-H的常规分析.
- 该方法是根据AGREE和GAPI评估的环境可持续的.
关键词:
在CLHP中,CLHP是最重要的.卢拉西的化强迫降级的高中强度降低,降低了力量的降低.在位地植入植入物.在现场植入植入物.卢拉西胺化稳定性指标的方法.在 PLGA PLGA 中.在RP-HPLC中使用.稳定性指示方法 稳定性指示方法更多相关视频
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