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用激光诱导分解光谱学结合多变量方法对药片的同质性分析

Amir Hossein Farhadian¹, Maedeh Mollaei²

¹Photonics and Quantum Technologies Research School, Nuclear Science and Technology Research Institute, Tehran, Iran.

European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V

|November 15, 2024

概括

激光诱导分解光谱 (LIBS) 有效地分析药物片的同质性和化学成分. 这种技术证实了洛萨坦片的可接受均性,这对于准确的患者剂量至关重要.

科学领域:

分析化学分析化学
材料科学材料科学材料科学
制药科学制药科学

背景情况:

药物片的同质性对于准确的剂量至关重要,尤其是在分片时.
确保均的化学成分可以防止治疗失败或不良影响.

研究的目的:

评估使用激光诱导分解光谱 (LIBS) 评估洛萨坦片的同质性和化学成分的可行性.
建立LIBS作为药品制造中可行的质量控制方法.

主要方法:

在洛萨坦片上从多个点获取LIBS光谱.
分析光谱数据以确定元素组成 (C,H,N,O,Ca,K,Ti).
计算等离子体参数 (温度,电子密度) 和应用统计方法 (RSD,PCA) 来进行同质性评估.

主要成果:

LIBS成功地确定了平板电脑核心 (Ca,K) 和涂层 (Ti) 中的关键元素.
等离子体特征证实了局部热力学平衡,符合麦克威特标准.
主要组件分析和相对标准偏差表明平板电脑核心与涂层相比具有优越的同质性,被认为是可以接受的.

结论:

LIBS是一种适合分析药片化学成分和同质性的技术.
该研究表明,洛萨坦片具有可接受的均性,支持其在质量控制中的使用.
LIBS提供了一种快速有效的药品质量保证方法.

关键词:

不同质性的不均质性激光诱导分解光谱学 (LIBS) 是一种技术.洛萨坦酸的使用方法药物药片药片药片药片主要组成部分分析 (PCA)

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