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用于评估纯品、药品及生物材料中诺氟沙星的简单比色法的开发与验证。

Development and validation of simple colorimetric methods for assessing norfloxacin in pure form, in pharmaceutical products and in biological material.

作者信息

Khan Muhammad Naeem, Adnan Muhammad, Bibi Nusrat, Kamal Asif, Mustafa Abd El-Zaher M A, Ali Iftikhar

机构信息

Department of Chemistry, Allama Iqbal Open University, Islamabad, 44000, Pakistan.

Iqbal Ahmad Qarshi Laboratory, Qarshi Industries (Pvt.), Ltd., Hattar Haripur, Pakistan.

出版信息

BMC Pharmacol Toxicol. 2025 Apr 7;26(1):75. doi: 10.1186/s40360-025-00916-0.

Abstract

Two straightforward, affordable, accurate, and spectrophotometric techniques gross developed to assess norfloxacin, formulations, and biological samples. The oxidation of norfloxacin will be done in technique (A) in acid solution with help of Fe(III). A wavelength of 511 nm with a correlation coefficient of 0.9879 was produced by the resulting Fe(II) coupled with 1,10-phenanthroline and the red colour complex. A uniform absorbance ranging from 1 to 30 µg/mL was discovered. Similarly, in procedure (B), in an acidic medium, Ce(IV) was added to norfloxacin. After reacting with a specific amount of methyl orange, the residual Ce(IV) is then determined. An absorbance measurement at 508 nm and a correlation coefficient of 0.9966 indicate a straight-line relationship between the two variables for concentration range is 1-15 µg/mL. The procedures were developed after a careful analysis of the several elements that influence the reaction process. After calculations, the LOD (limits of detection) and LOQ (limit of quantification) were determined to be 1.098 and 1.111 µg/mL for method A and 2.875 and 3.368 µg/mL for method B respectively. The method B has also been applied for the determination of norfloxacin in spiked human plasma and urine samples. The percentage recoveries ranged from 98.74 to 103.43% and from 98.17 to 100.85% for plasma and urine samples, respectively. Proposed techniques have been successfully used for the examination of biological fluids, formulations for medicines as well as pure norfloxacin following statistical validation through recovery studies.

摘要

已经开发出两种简单、经济、准确的分光光度技术来评估诺氟沙星、制剂和生物样品。在技术(A)中,诺氟沙星在酸性溶液中借助Fe(III)进行氧化。生成的Fe(II)与1,10-菲啰啉和红色络合物产生了波长为511 nm、相关系数为0.9879的结果。发现吸光度在1至30 μg/mL范围内均匀。同样,在方法(B)中,在酸性介质中,将Ce(IV)加入到诺氟沙星中。与特定量的甲基橙反应后,然后测定残留的Ce(IV)。在508 nm处的吸光度测量和0.9966的相关系数表明,浓度范围为1-15 μg/mL时,两个变量之间呈直线关系。在仔细分析影响反应过程的几个因素后开发了这些方法。经过计算,方法A的检测限(LOD)和定量限(LOQ)分别确定为1.098和1.111 μg/mL,方法B的检测限和定量限分别为2.875和3.368 μg/mL。方法B也已应用于加标人血浆和尿液样品中诺氟沙星的测定。血浆和尿液样品的回收率分别为98.74%至103.43%和98.17%至100.85%。通过回收率研究进行统计验证后,所提出的技术已成功用于生物体液、药物制剂以及纯诺氟沙星的检测。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/aac6/11978087/0ca5ae6e31dc/40360_2025_916_Fig1a_HTML.jpg

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