伊维菌素和克罗苏伦混合药的绿色智能定量质量控制:基于分析生态尺度、绿色分析程序指数和分析绿色度度量方法的光谱分析生态评价。

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/qsad098
Miranda F Kamal, Rasha M Youssef, Samir Morshedy, Nehal W El Sayed
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引用次数: 1

摘要

背景:全球金融市场仍然受到牛筋膜炎的高度威胁,这是一种主要针对热带地区牛的寄生虫感染。伊维菌素(IVER)和克洛苏龙(CLO)的二元组合,以具有挑战性的浓度比,通常用于治疗和控制筋膜炎。目的:本研究旨在智能同时分光光度法测定两种化合物在市场配方和合成混合物中的高比例,而无需任何事先分离。此外,还对其绿色度进行了评估,并将其与之前报道的分析方法(包括官方方法)进行了比较。方法:基于数学提出的方法有双波长法、诱导双波长法和一阶导数比法。每种都经过开发、优化和应用,可在1-30和5-40的线性范围内同时确定IVER和CLO μg/mL。它们已根据ICH指南进行了验证。统计学生t检验和F检验将所提出的方法与USP色谱技术进行了比较。生态评估使用三个独立的指标来完成:分析生态量表(AES)、绿色分析程序指数(GAPI)和分析绿色度量方法(AGREE)。结果:获得了令人满意的回收率、ICH依从性以及所提出的方法对生态安全裕度的遵守。结论:所开发的方法环境友好,成本效益高,可以实现两种药物同时测定的常规定量质量控制。亮点:兽医抗菌药物需要使用更安全和绿色的方法进行分析质量控制。以1:10%(v/v)的比例对IVER和CLO的数据操纵光谱分析进行了开发和优化。AES、GAPI和AGREE方法说明了文献中报道的测定的高绿色依从性。此外,美国药典(USP)对注射剂型的IVER和CLO的测定取决于在另一种药物存在的情况下分别对每种药物进行分析,但不能同时测定这两种药物。
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Green and Smart Quantitative Quality Control for Veterinary Mixture of Ivermectin and Clorsulon: Ecological Evaluation of Spectral Analyses via Analytical Eco-Scale, Green Analytical Procedure Index, and Analytical GREEnness Metric Approaches.

Background: The global financial market is still highly threatened by bovine fasciolosis, a parasitic infection that targets cattle, mainly in tropical regions. Binary combination of ivermectin (IVER) and clorsulon (CLO), in challenging concentration ratios, is typically indicated for treatment and control of fasciolosis.

Objective: The present study aims at smart simultaneous spectrophotometric assay of both compounds at their high ratio in marketed formulation and synthetic mixtures, without any prior separation. Furthermore, their greenness profile was evaluated and compared with previous reported assay methods, including the official one.

Methods: Mathematical-based proposed methods are the dual-wavelength, induced dual-wavelength, and first derivative ratio methods. Each is developed, optimized, and applied to determine simultaneously IVER and CLO at linear ranges of 1-30 and 5-40 μg/mL, respectively. They have been validated according to ICH guidelines. Statistical Student t-tests and F-tests compared the proposed methods with a USP chromatographic technique. Ecological appraisal is accomplished using three independent metrics: Analytical Eco-Scale (AES), Green Analytical Procedure Index (GAPI), and Analytical GREEnness Metric Approach (AGREE).

Results: Satisfactory recoveries, ICH compliance, and adherence of proposed methods to the ecological safety margin are achieved.

Conclusions: Developed methods are eco-friendly and cost-effective and can accomplish a routine quantitative quality control for concurrent determination of both drugs.

Highlights: Veterinary antimicrobials need analytical quality control using safer and green methodologies. Data manipulated spectral analyses of IVER and CLO, in a ratio of 1:10% (v/v), are developed and optimized. AES, GAPI, and AGREE approaches illustrate the high green compliance in respect to assays reported in the literature. Furthermore, the United States Pharmacopeia (USP) assay for IVER and CLO in injectable dosage form depends on analysis of each drug separately in the presence of the other drug, but it cannot determine both drugs simultaneously.

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来源期刊
Journal of AOAC International
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.
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