基于连续波形变换和比率减去方法的光谱光度法,用于快速同时量化心血管药片配方中的瓦尔萨坦,阿姆洛迪平和甲酸
Saeedeh Hajilo1, Mahmoud Reza Sohrabi1
1Department of Chemistry, North Tehran Branch, Islamic Azad University, Tehran, Iran.
Spectrochimica acta. Part A, Molecular and biomolecular spectroscopy
|January 11, 2025
概括
这项研究介绍了两种化学光谱光度测量方法,用于同时量化瓦尔佐米克斯HCT片中的甲酸,瓦尔萨坦和阿姆洛迪平. 这两种方法都提供了准确可靠的分析,不需要样本准备.
科学领域:
- 分析化学 分析化学
- 药品分析 药品分析
- 化学测量 化学测量 化学测量
背景情况:
- 精确量化药品活性成分 (API) 对于药品质量控制至关重要.
- 瓦尔佐米克斯HCT片含有酸 (HCT),瓦尔萨坦 (VAL) 和阿姆洛迪平 (AML),需要同时确定.
- 现有的分析方法可能耗时或需要复杂的样本准备.
研究的目的:
- 开发和验证两种快速,无分离的光谱光学方法,用于同时确定HCT,VAL和AML.
- 为了比较连续波形变换 (CWT) 和比率减去 (RS) 化学测量技术的性能.
- 评估这些方法对于Valzomix HCT药片的常规质量控制的适用性.
主要方法:
- 使用化学测量技术进行光谱光度分析:连续波形变换 (CWT) 和比率减去 (RS).
- CWT方法涉及在特定波长的特定波点 (Daubechies 2, Symlet 2, Biorthogonal 1.3) 应用零交叉分析.
- 用RS方法直接进行光谱测量分析,没有先前分离药物成分.
主要成果:
- 无论是CWT和RS方法都实现了HCT,VAL和AML的准确和精确量化.
- CWT显示量化和检测极限低 (0.0406-0.3906μg/mL),恢复率高 (>97%) 和RMSE低 (<2).
- RS显示了良好的恢复率 (99.52%-102.70%) 和量化极限 (0.3064-0.7669μg/mL). 两种方法均显示相对标准偏差低于1%.
结论:
- 开发的CWT和RS光谱光学方法在Valzomix HCT片中有效地同时确定HCT,VAL和AML.
- 这些方法是快速的,不需要样本准备,并提供高准确度和精度,适合质量控制.
- 统计分析 (ANOVA) 证实,所采用的方法之间没有显著差异.
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