Green Method for Evaluation of Marbofloxacin Tablets by HPLC and Evaluation of Interchangeability With UV and Turbidimetric Methods.

IF 1.7 4区农林科学 Q3 CHEMISTRY, ANALYTICAL Journal of AOAC International Pub Date : 2023-11-02 DOI:10.1093/jaoacint/qsad102

Aline Sinzervinch de Oliveira, Naiara Raica Lopes de Oliveira, Jerônimo Raimundo de Oliveira Neto, Layla Lopes Tavares, Ana Carolina Kogawa

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Abstract

Background: Marbofloxacin (MAR) is a veterinary antimicrobial, marketed in injectable solution, oral suspension, and tablets. MAR has no monograph for tablet evaluation in official compendiums. High Performance Liquid Chromatography (HPLC) methods present in the literature for evaluating MAR in tablets do not follow the principles of green and sustainable analytical chemistry.

Objective: A green, clean, and sustainable method by HPLC was developed and validated to evaluate the content and stability of MAR in tablets, in addition to comparing it with other methods available in the literature.

Method: A C8, 5 µm, 4.6 × 150 mm (ACE®) column, purified water with 0.2% formic acid-ethanol (70:30, v/v) as the mobile phase, and a flow rate of 0.7 mL/min at 296 nm were used.

Results: The method was linear over a concentration range of 1-10 μg/mL, selective for tablet matrix and forced degradation, precise with relative standard deviations (RDS) less than 5%, accurate with recovery of 99.99%, and robust to changes in the mobile phase, flow rate, wavelength, equipment, and column brand. The retention time for MAR was approximately 3.1 min.

Conclusions: The method can be used in routine analysis of MAR in tablets in chemical-pharmaceutical laboratories. Furthermore, it can be used to verify the stability of MAR-based products and proved to be interchangeable with spectrophotometric method in the UV region and turbidimetric microbiological method.

Highlights: A green method for evaluation of marbofloxacin tablets by HPLC was developed and validated. Additionally, it has been shown to be interchangeable with UV and turbidimetric methods.

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高效液相色谱法评价马布沙星片的绿色方法及与紫外和浊度法的互换性评价。

背景：马波沙星（MAR）是一种兽医抗菌药物，以注射溶液、口服混悬液和片剂的形式上市。MAR在官方汇编中没有关于片剂评价的专著。文献中用于评估片剂中MAR的高效液相色谱（HPLC）方法不符合绿色和可持续分析化学的原则。目的：建立并验证了一种绿色、清洁、可持续的高效液相色谱法来评价MAR在片剂中的含量和稳定性，并与文献中的其他方法进行了比较。方法：A C8，5 µm，4.6×150 mm（ACE®）柱，流动相为0.2%甲酸乙醇（70:30，v/v）的纯化水，流速为0.7 296时为mL/min nm。结果：该方法在1-10的浓度范围内呈线性 μg/mL，对片剂基质和强制降解具有选择性，精密度相对标准偏差（RDS）小于5%，准确度回收率为99.99%，对流动相、流速、波长、设备和柱品牌的变化具有鲁棒性。MAR的保留时间约为3.1 结论：该方法可用于化学制药实验室片剂中MAR的常规分析。此外，它可用于验证MAR基产品的稳定性，并被证明可与紫外区域的分光光度法和浊度微生物法互换。亮点：建立并验证了高效液相色谱法评价马波沙星片的绿色方法。此外，它已被证明可以与紫外线和浊度法互换。

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来源期刊

Journal of AOAC International 医学-分析化学

CiteScore

3.10

自引率

12.50%

发文量

144

审稿时长

2.7 months

期刊介绍： The Journal of AOAC INTERNATIONAL publishes the latest in basic and applied research in analytical sciences related to foods, drugs, agriculture, the environment, and more. The Journal is the method researchers'' forum for exchanging information and keeping informed of new technology and techniques pertinent to regulatory agencies and regulated industries.