在复杂的局部配方中应用到NIR的AQbD方法:作为案例研究的Bifonazole.
Lucas Chiarentin1,2,3,4, Vera Moura3, Alberto A C C Pais4
1Faculty of Pharmacy, University of Coimbra, Pólo das Ciências da Saúde, Azinhaga de Santa Comba, 3000-548 Coimbra, Portugal.
Pharmaceutics
|July 30, 2025
概括
靠近红外光谱 (NIR) 和RP-HPLC方法,以设计分析质量 (AQbD) 为指导,准确量化乳液中的双醇 (BFZ). 这些经过验证的模型为药品质量控制提供了可靠的替代方案.
科学领域:
- 制药科学 制药科学
- 分析化学 分析化学
- 频谱学是一种光谱学.
背景情况:
- 在制药研究中,开发药物配方行为的预测模型至关重要.
- 近红外光谱 (NIR) 为传统方法提供了一种非破坏性的,化学特异性的替代方案.
- 了解分子特性是可靠的预测配方工具的关键.
研究的目的:
- 应用部分分析质量通过设计 (AQbD) 方法来增强NIR和RP-HPLC方法.
- 开发和验证乳配方中的双醇 (BFZ) 量化化学模型.
- 为制药品质量控制建立可靠的分析方法.
主要方法:
- 利用近红外光谱学 (NIR) 与多变量数据分析用于化学建模.
- 采用RP-HPLC来评估关键性能参数,如峰值区域和测试.
- 定义了一个分析目标配置文件 (ATP),并使用石川图进行风险评估.
主要成果:
- 开发了精确的量化模型,用于乳配方中的双醇 (BFZ).
- 实现了精确的BFZ含量测定:8.48 mg (NIR) 和8.34 mg (RP-HPLC) 与1.25%的RSD.
- 证明了NIR和RP-HPLC方法的可靠性和稳定性.
结论:
- 开发的NIR和RP-HPLC模型适用于BFZ配方的常规质量控制.
- 未来的工作应该探索实时透监测和整合到监管框架.
- 建议在药品质量控制和配方开发中标准化NIR应用.
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