基于atr - ftir的左氧氟沙星、降解和掺假直接快速定量分析

IF 4.1 Q2 CHEMISTRY, ANALYTICAL
Muhammad Umair Kamal, Raja Adil Sarfraz, Rizwan Ashraf, Muhammad Kashif, Muhammad Imran
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引用次数: 0

摘要

快速和直接的药物定量对于制药部门的质量控制单位来说是必不可少的,以确保安全配方和向患者提供正确的药物。研究了左氧氟沙星(LFX)的光谱特征,为固体制剂中左氧氟沙星(LFX)的快速定量分析提供了一种基于傅里叶变换红外光谱(FTIR)的快速实用分析方法。建立了1252.39 ~ 1218.84 cm−1频率域的化学计量模型,该模型在30% ~ 90% (w/w)范围内呈线性,决定系数(R2) 0.995,满足国际协调理事会(ICH)和AOAC对该方法发展的要求。检测限(LOD)和定量限(LOQ)分别为7.616%和23.079% w/w。主成分分析(PCA)用于鉴别掺假或降解的活性药物成分(api)。结果表明,PC1和PC2分别解释了99.93%和99.91%的红外光谱方差。因此,该方法可用于LFX的常规分析和药品监管实验室的质量控制。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

ATR–FTIR-Based Direct and Rapid Quantification of Levofloxacin, Degradation and Adulterations via Multivariate Analysis

ATR–FTIR-Based Direct and Rapid Quantification of Levofloxacin, Degradation and Adulterations via Multivariate Analysis

The rapid and direct drug quantification is indispensable for quality control units in the pharmaceutical sector to assure safe formulation and delivery of the right medicine to patients. Spectral features of Levofloxacin (LFX) were examined to provide a Fourier transform infrared spectroscopy (FTIR)-based rapid and pragmatic analytical method for direct quantification of LFX in solid formulations. A chemometric model was developed for frequency region of 1252.39–1218.84 cm−1 which is linear over the range of 30%–90% (w/w) with a coefficient of determination (R2) 0.995 and meets the requirements of International Council for Harmonization (ICH) and AOAC for the development of the method. The limit of detection (LOD) and limit of quantification (LOQ) were found to 7.616% w/w and 23.079% w/w, respectively. Principal component analysis (PCA) was performed to identify adulteration or degradation of active pharmaceutical ingredients (APIs). It was observed that PC1 and PC2 explained 99.93% and 99.91% of the IR spectral variance respectively. Consequently, this method can be applied for routine analysis of LFX and quality control in pharmaceutical regulatory laboratories.

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CiteScore
4.60
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