通过设计驱动的分析质量,开发和验证紫外可见光谱光度测量方法,用于批量和固体脂质纳米颗粒中Xanthohumol的量化
Harish Vancha1, Devesh Tewari2, Rajesh Kumar1
1Lovely Professional University, School of Pharmaceutical Sciences, Phagwara, Punjab, India.
Turkish journal of pharmaceutical sciences
|July 7, 2023
概括
一种新的设计质量 (QbD) 紫外线光谱法准确地量化纳米配方中的索 (XH). 这种经过验证的方法克服了XH和XH.
科学领域:
- 分析化学 分析化学
- 制药科学 制药科学
- 纳米技术纳米技术
背景情况:
- 尚索醇 (XH) 是一种先化石,表现出多种药理活性,但在生物转化和胃肠道吸收方面存在局限性.
- 为了提高XH的生物可用性,开发了纳米配方,特别是固体脂质纳米粒子 (SLN).
- 在这些纳米配方中精确量化XH对于质量控制和进一步研究至关重要.
研究的目的:
- 开发和验证基于设计质量 (QbD) 的紫外线 (UV) 光谱光度法,用于索醇 (XH) 估计.
- 确保该方法适用于量化XH在散装形式和固体脂质纳米颗粒 (SLN) 中的适用性.
- 遵守国际协调会议 (ICH) Q2 (R1) 关于分析方法验证的指南.
主要方法:
- 采用了QbD方法,涉及风险评估以确定关键方法变量.
- 使用中央复合设计 (CCD) 模型优化方法变量.
- 开发的紫外光谱光度法根据ICH Q2 (R1) 准则进行了验证,评估了线性,精度,准确性,LOD,LOQ和特异性.
主要成果:
- 基于QbD的模型显示出非常好的匹配 (R2 = 0.8698).
- 经过验证的方法证明了高线性 (R2=0.9981在2-12μg/mL之间),准确性 (99.3-100.1%的回收率) 和精度 (%RSD<2).
- 检测极限 (LOD) 为0.77微克/毫升,量化极限 (LOQ) 为2.36微克/毫升.
结论:
- 成功开发了一种强大且经过验证的紫外线光谱测量方法,用于批量和SLN中Xanthohumol (XH) 估计.
- 该方法被证明是XH的特异性,在可接受的范围内满足所有验证参数.
- 这种分析工具适用于XH纳米配方的质量控制和表征.
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