Miranda F Kamal, Rasha M Youssef, Samir Morshedy, Nehal W El Sayed
{"title":"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。","authors":"Miranda F Kamal, Rasha M Youssef, Samir Morshedy, Nehal W El Sayed","doi":"10.1093/jaoacint/qsad098","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Objective: </strong>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.</p><p><strong>Methods: </strong>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).</p><p><strong>Results: </strong>Satisfactory recoveries, ICH compliance, and adherence of proposed methods to the ecological safety margin are achieved.</p><p><strong>Conclusions: </strong>Developed methods are eco-friendly and cost-effective and can accomplish a routine quantitative quality control for concurrent determination of both drugs.</p><p><strong>Highlights: </strong>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.</p>","PeriodicalId":15003,"journal":{"name":"Journal of AOAC International","volume":" ","pages":"1455-1463"},"PeriodicalIF":1.7000,"publicationDate":"2023-11-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"1","resultStr":"{\"title\":\"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.\",\"authors\":\"Miranda F Kamal, Rasha M Youssef, Samir Morshedy, Nehal W El Sayed\",\"doi\":\"10.1093/jaoacint/qsad098\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Objective: </strong>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.</p><p><strong>Methods: </strong>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).</p><p><strong>Results: </strong>Satisfactory recoveries, ICH compliance, and adherence of proposed methods to the ecological safety margin are achieved.</p><p><strong>Conclusions: </strong>Developed methods are eco-friendly and cost-effective and can accomplish a routine quantitative quality control for concurrent determination of both drugs.</p><p><strong>Highlights: </strong>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. 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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.
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.