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Updated: Jul 10, 2026

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绿色HPLC-光方法用于坦素和索利芬素,用盒式设计优化剂型

Khalid M Badr El-Din¹, Sayed M Derayea¹, Ahmed S Ahmed²

¹Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Minia University, Minia, Egypt.

Luminescence : the journal of biological and chemical luminescence

|November 24, 2025

概括

一种新的HPLC方法准确量化了坦苏洛辛和索利芬素 (TAM/SOL) 混合物. 这种环保的方法确保了药物组合产品的精确分析,并遵守绿色化学原则.

科学领域:

分析化学分析化学
药品分析药品分析

背景情况:

准确量化药物混合物对于制药质量控制至关重要.
坦素和索利费纳是常见的处方药,通常用于组合疗法.

研究的目的:

开发和验证一个环保和精确的高性能液体染色学 (HPLC) 方法,用于同时确定坦苏洛辛和索利芬素.
评估该方法是否适合分析组合剂型,以及是否符合绿色化学原则.

主要方法:

使用Box-Behnken设计优化HPLC条件.
在具有光检测的C18柱上实现分离.
验证线性,检测极限 (LOD) 和量化 (LOQ).

主要成果:

该方法证明了tamsulosin和solifenacin的优异分离,具有特定的保留时间.
在定义的度范围内获得了线性校准曲线.
在剂量形式中实现了高恢复率 (tamsulosin的恢复率为100.50%,solifenacin的恢复率为100.39)
该方法成功评估了组合药片的内容统一性.

结论:

开发的HPLC方法是精确的,敏感的,并且对tamsulosin和solifenacin的并发分析环保.
该方法适用于组合制药配方的质量控制和内容统一性测试.
该研究强调了坚持绿色化学原则,并通过GAPI和AGREE工具进行验证.

关键词:

在HPLC-光学.内容统一性测试内容统一性测试这就是所谓的solifenacin.塔姆苏洛辛 (tamsulosin) 是一种类型的药物.

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