Design of Experiment-Based Green UPLC-DAD Method for the Simultaneous Determination of Indacaterol, Glycopyrronium and Mometasone in their Combined Dosage Form and Spiked Human Plasma.

IF 16.4 1区化学 Q1 CHEMISTRY, MULTIDISCIPLINARY

Accounts of Chemical Research Pub Date : 2024-08-20 DOI:10.1093/chromsci/bmad072

Mohamed Tarek, Nermine S Ghoniem, Maha A Hegazy, Hebatallah A Wagdy

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Abstract

Indacaterol, is an ultra-long-acting β2 agonist, glycopyrronium is a long-acting muscarinic-antagonist and mometasone is a synthetic corticosteroid. They were used recently in combination for the treatment of severe asthma symptoms and chronic obstructive pulmonary disease. In this work, it was the first time to develop a green and environment friendly ultra-performance liquid chromatographic method using design expert program for the analysis of the three drugs in their combined dosage form. Also, the method was bioanalytically validated for the analysis of the three drugs in spiked human plasma samples. The method was linear in range from 0.50 to 100.0 μg mL-1 for indacaterol and mometasone and from 1.0 to 150.0 μg mL-1 for glycopyrronium. It showed high accuracy where, the % recovery for indacaterol, glycopyrronium and mometasone in plasma were ranged from 94.27 to 97.86%, 96.43 to 98.75% and 96.86 to 98.43%, respectively. Also, it was precise where, the % relative standard deviation for the inter-day precision was ranged from 2.571 to 3.484%, 3.180 to 4.123% and 3.150 to 3.984% and the intra-day precision was ranged from 2.351 to 3.125%, 2.512 to 3.544% and 2.961 to 3.983% for indacaterol, glycopyrronium and mometasone, respectively. The limit of detection and the limit of quantification for indacaterol and mometasone were 0.03 and 0.10 μg mL-1 while for glycopyrronium, they were 0.16 and 0.50 μg mL-1.

Highlights:

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基于实验设计的绿色 UPLC-DAD 法同时测定茚达特罗、甘草酸铵和莫美他松的复方制剂和加标人体血浆。

茚达特罗是一种超长效β2受体激动剂，甘珀酸是一种长效毒蕈碱受体激动剂，莫米他松是一种合成皮质类固醇。最近，它们被联合用于治疗严重的哮喘症状和慢性阻塞性肺病。在这项工作中，首次利用设计专家程序开发了一种绿色环保的超高效液相色谱法，用于分析这三种药物的复合剂型。此外，该方法还对人体血浆样品中三种药物的加标分析进行了生物分析验证。茚达特罗和莫美他松的线性范围为 0.50-100.0 μg mL-1，甘草酸苷的线性范围为 1.0-150.0 μg mL-1。该方法的准确度很高，血浆中茚达特罗、甘草酸铵和莫美他松的回收率分别为 94.27% 至 97.86%、96.43% 至 98.75% 和 96.86% 至 98.43%。茚达特罗、甘草酸铵和莫美他松的日间精密度相对标准偏差分别为 2.571%至 3.484%、3.180%至 4.123%和 3.150%至 3.984%，日内精密度分别为 2.351%至 3.125%、2.512%至 3.544%和 2.961%至 3.983%。茚达特罗和莫美他松的检出限和定量限分别为 0.03 和 0.10 μg mL-1，而甘草酸铵的检出限和定量限分别为 0.16 和 0.50 μg mL-1：

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来源期刊

Accounts of Chemical Research 化学-化学综合

CiteScore

31.40

自引率

1.10%

发文量

312

审稿时长

2 months

期刊介绍： Accounts of Chemical Research presents short, concise and critical articles offering easy-to-read overviews of basic research and applications in all areas of chemistry and biochemistry. These short reviews focus on research from the author’s own laboratory and are designed to teach the reader about a research project. In addition, Accounts of Chemical Research publishes commentaries that give an informed opinion on a current research problem. Special Issues online are devoted to a single topic of unusual activity and significance. Accounts of Chemical Research replaces the traditional article abstract with an article "Conspectus." These entries synopsize the research affording the reader a closer look at the content and significance of an article. Through this provision of a more detailed description of the article contents, the Conspectus enhances the article's discoverability by search engines and the exposure for the research.