创新的左氧氟沙星双技术测定方法:分光光度螯合和微流体纸基系统加强药品质量控制

IF 1.1 4区 化学 Q4 CHEMISTRY, ANALYTICAL
Teeba D. Khamis,  Raed F. Hassan
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引用次数: 0

摘要

本研究介绍了一种双技术左氧氟沙星定量策略,结合紫外可见分光光度法和微流控纸基分析装置(µPAD),以满足成本效益高、精确的药物质量控制需求。利用左氧氟沙星和氯酚红之间的反应,两种方法通过静电和氢键稳定的酸碱相互作用形成彩色配合物(λmax = 574 nm)。该方法灵敏度高(检出限:2.50µg/mL,线性范围:5 ~ 100µg/mL),日内(相对标准偏差:0.946 ~ 1.730%)、日内精密度(RSD: 1.401 ~ 2.198%)、日内回收率为91.5 ~ 102.6%。相比之下,µPAD提供便携性和快速分析(LOD: 10.119µg/mL,线性范围:100-1000µg/mL),以最小的试剂消耗实现相当的准确度(回收率:90.6-96.1%)。这两种技术都根据国际协调理事会的准则进行了验证,在商业配方(左旋氧氟沙星、左旋巴act、左旋氧氟沙星Vitapure)中显示出可忽略不计的基质干扰。分光光度法在实验室环境中具有卓越的精度,而µPAD可进行现场测试,符合绿色化学原则。这种双重方法弥补了技术差距,提供了多种工具,以确保准确给药,支持抗微生物药物管理,并加强全球药品质量控制。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Innovative Dual-Technique Approach to Levofloxacin Assay: Spectrophotometric Chelation and Microfluidic Paper-Based System for Enhanced Pharmaceutical Quality Control

Innovative Dual-Technique Approach to Levofloxacin Assay: Spectrophotometric Chelation and Microfluidic Paper-Based System for Enhanced Pharmaceutical Quality Control

This study introduces a dual-technique strategy for levofloxacin quantification, combining ultraviolet-visible spectrophotometry and a microfluidic paper-based analytical device (µPAD) to address the need for cost-effective, precise pharmaceutical quality control. Leveraging the reaction between levofloxacin and chlorophenol red, both methods form a colored complex (λmax = 574 nm) via an acid-base interaction stabilized by electrostatic and hydrogen bonding. The spectrophotometric method demonstrates high sensitivity (limit of detection (LOD): 2.50 µg/mL, linear range: 5–100 µg/mL) with robust intra-day (relative standard deviation (RSD): 0.946–1.730%) and inter-day precision (RSD: 1.401–2.198%), alongside recovery rates of 91.5–102.6%. In contrast, the µPAD offers portability and rapid analysis (LOD: 10.119 µg/mL, linear range: 100–1000 µg/mL), achieving comparable accuracy (recovery: 90.6–96.1%) with minimal reagent consumption. Both techniques were validated according to the International Council for Harmonization guidelines, exhibiting negligible matrix interference in commercial formulations (Levolen, Levobact, Levofloxacin Vitapure). The spectrophotometric method excels in laboratory settings for precision, while the µPAD enables on-site testing, aligning with green chemistry principles. This dual approach bridges technological gaps, providing versatile tools to ensure accurate dosing, support antimicrobial stewardship, and enhance global pharmaceutical quality control.

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来源期刊
Journal of Analytical Chemistry
Journal of Analytical Chemistry 化学-分析化学
CiteScore
2.10
自引率
9.10%
发文量
146
审稿时长
13 months
期刊介绍: The Journal of Analytical Chemistry is an international peer reviewed journal that covers theoretical and applied aspects of analytical chemistry; it informs the reader about new achievements in analytical methods, instruments and reagents. Ample space is devoted to problems arising in the analysis of vital media such as water and air. Consideration is given to the detection and determination of metal ions, anions, and various organic substances. The journal welcomes manuscripts from all countries in the English or Russian language.
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