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在ATR-FTIR基础上通过多变量分析直接和快速量化莱沃弗洛克萨辛,降解和改

Muhammad Umair Kamal¹, Raja Adil Sarfraz¹, Rizwan Ashraf¹

¹Department of Chemistry University of Agriculture Faisalabad Pakistan.

Analytical science advances

|October 6, 2025

概括

这项研究引入了一种快速里埃变换红外光谱法 (FTIR) 方法,用于在制药配方中量化利沃素 (LFX). 开发的化学测量模型确保了准确的药物分析以进行质量控制.

科学领域:

分析化学分析化学
制药科学制药科学
频谱学是一种光谱学.

背景情况:

准确的药物量化对于制药质量控制至关重要.
列沃素 (LFX) 需要可靠的分析方法来保证配方的可靠性.
现有的方法可能无法为例行分析提供所需的速度或直接性.

研究的目的:

开发一种快速和直接的分析方法,用于在固体配方中量化利沃素.
建立基于Fourier变换红外光谱法 (FTIR) 的方法,使用化学测量.
根据国际协调委员会 (ICH) 和AOAC指南验证该方法.

主要方法:

利用里叶变换红外光谱法 (FTIR) 来分析莱沃素的光谱特征.
在1252.39-1218.84厘米-1频率区域内开发了一种化学测量模型.
应用主要成分分析 (PCA) 用于伪造和降解分析.
确定方法的性能,包括线性,检测极限 (LOD) 和量化极限 (LOQ).

主要成果:

在30%-90% (w/w) 范围内实现了LFX的线性量化模型 (R2 = 0.995).
已确定的LOD为7.616%w/w和LOQ为23.079%w/w.
PCA显示了高光谱方差解释 (PC1: 99.93%,PC2: 99.91%),表明了方法的稳定性.
该方法符合ICH和AOAC对分析方法开发的要求.

结论:

开发的基于FTIR的化学测量方法为直接量化Levofloxacin提供了快速和务实的方法.
该技术适用于制药监管实验室的常规分析和质量控制.
该方法在固体配方中的LFX分析中表现出高精度,线性和稳定性.

关键词:

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