开发和验证一种简单的方法,用于测定鼻喷雾中氨酸胺的含量
Haya S Alzeer1, Shikah F Alzaid1, Fahad S Aldawsari1
1Reference Laboratory for Medicines and Cosmetics (RLMC), Saudi Food and Drug Authority (SFDA), Riyadh 12843-7116, Saudi Arabia.
概括
一种新的紫外光谱光度法准确地量化了鼻喷雾中的三氨乙化物 (TAC). 这种快速的技术为药品分析提供了HPLC的可靠替代方案.
科学领域:
- 分析化学 分析化学
- 药品分析 药品分析
背景情况:
- 氨酸 (TAC) 是一种常用于鼻喷雾配方的皮质类固醇.
- 药物剂型中TAC的准确量化对于确保治疗疗效和患者安全至关重要.
研究的目的:
- 开发和验证一种快速,方便和灵敏的分析技术,用于在药品鼻喷雾剂型中对triamcinolone acetonide (TAC) 的定量分析.
- 确定紫外光谱光度计方法的适用性,作为官方综合方法的替代方法.
主要方法:
- 开发和验证使用蓝色四色度反应的紫外光谱光度计方法.
- 评估线性,量化极限 (LOQ),精度 (可重复性和中间精度) 和准确性 (回收研究).
- 开发的紫外线方法与官方美国药典 (USP) 高性能液体染色学 (HPLC) 测定程序的比较.
主要成果:
- 开发的紫外线方法在10-40μg/mL的度范围内证明了线性 (R2 = 0.998).
- 确定LOQ为9.99微克/毫升,相对标准偏差 (RSD) 为0.26%.
- 高精度 (RSD ≤2.01%) 和准确度 (平均回收100.08-103.65%) 实现,结果与官方HPLC方法相比显示良好一致.
结论:
- 拟议的紫外光谱光度法是一种快速,灵敏和可重复的技术,用于在鼻喷雾配方中定量确定triamcinolone乙化物.
- 这种紫外线方法是官方USPHPLC测定的可行替代方法,有可能在制药质量控制中常规应用.
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