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利用呫吨染料对多粘菌素注射剂进行全绿色检测:在含量均匀度检测中的应用

Full green assay of parenteral dosage forms of polymyxins utilizing xanthene dye: application to content uniformity testing.

作者信息

Abdelmajed Mahmoud A, El-Din Khalid M Badr, Attia Tamer Z, Omar Mahmoud A

机构信息

Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Deraya University, New Minia, Egypt.

Department of Analytical Chemistry, Faculty of Pharmacy, Minia University, Minia, Egypt.

出版信息

BMC Chem. 2024 Aug 27;18(1):158. doi: 10.1186/s13065-024-01261-9.

DOI:10.1186/s13065-024-01261-9
PMID:39192355
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11350942/
Abstract

Due to the lack of other treatment options, a rebirth of polymyxins is urgently required. Colistin (also called polymyxin E) and polymyxin B are the only two examples of this antibiotic class that were effectively employed in such critical situations. In the present work, both of the two studied medications were quantified via a simple, green, and non-extracting spectrophotometric approach based on the formation of ion-pair complexes with Erythrosine B. Without using any organic solvents, the pink color of the created complexes was detected at wavelength = 558 nm. To achieve the highest intensity of absorbance, optimum conditions were established by the screening of many experimental factors such as pH, buffer volume, the volume of Erythrosine B, and the time consumed to undergo the reaction. For Colistin and Polymyxin B respectively, Beer-Lambert's law was observed at the concentration ranges of 1-6, 1-9 µg mL. The technique was approved and validated following ICH recommendations. Lastly, the suggested approach has been successfully implemented to quantify the cited medications colorimetrically, for the first time, in their parenteral dosage forms with excellent recoveries. Also, Content uniformity testing was implemented.

摘要

由于缺乏其他治疗选择,迫切需要让多粘菌素重获新生。黏菌素(也称为多粘菌素E)和多粘菌素B是这类抗生素中仅有的两种在如此危急情况下得到有效应用的药物。在本研究中,基于与赤藓红B形成离子对络合物,通过一种简单、绿色且无需萃取的分光光度法对这两种研究药物进行了定量。无需使用任何有机溶剂,在波长 = 558 nm处检测到所形成络合物的粉红色。通过筛选许多实验因素,如pH值、缓冲液体积、赤藓红B的体积以及反应所需时间,确定了达到最高吸光度强度的最佳条件。对于黏菌素和多粘菌素B,分别在1 - 6、1 - 9 μg/mL的浓度范围内符合比尔-朗伯定律。该技术按照国际人用药品注册技术协调会(ICH)的建议进行了验证。最后,所建议的方法首次成功用于比色法定量上述药物的注射剂剂型,回收率良好。此外,还进行了含量均匀度测试。

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本文引用的文献

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BMC Chem. 2024 May 29;18(1):105. doi: 10.1186/s13065-024-01156-9.
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New validated spectrofluorimetric protocol for colistin assay through condensation with 2,2-dihydroxyindan-1,3-dione: application to content uniformity testing.通过与2,2-二羟基茚满-1,3-二酮缩合进行多粘菌素测定的新验证荧光分光光度法:在含量均匀度测试中的应用
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HPLC Determination of Colistin in Human Urine Using Alkaline Mobile Phase Combined with Post-Column Derivatization: Validation Using Accuracy Profiles.
高效液相色谱法结合碱性流动相和柱后衍生化测定人尿中的黏菌素:用准确度轮廓验证
Molecules. 2022 May 28;27(11):3489. doi: 10.3390/molecules27113489.
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Salvage parenteral antibiotics for multidrug-resistant (MDR) Gram-negative bacteria; a fluorescamine-based technique for ultrasensitive spectrofluorimetric measurement of Polymyxins; human plasma application.多药耐药(MDR)革兰氏阴性菌的补救性肠外抗生素;基于荧光胺的多粘菌素超灵敏光谱荧光法测定技术;人血浆应用。
Luminescence. 2022 Jun;37(6):971-979. doi: 10.1002/bio.4245. Epub 2022 Apr 18.
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Determination of polymyxin B in dried blood spots using LC-MS/MS for therapeutic drug monitoring.采用 LC-MS/MS 法测定干血斑中多黏菌素 B 的浓度以进行治疗药物监测。
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