开发用于同时测定皮质类固醇联合免疫疗法的高效液相色谱-紫外法。

IF 1.5 4区 化学 Q4 BIOCHEMICAL RESEARCH METHODS Journal of chromatographic science Pub Date : 2024-07-10 DOI:10.1093/chromsci/bmad050
Nessreen S Abdelhamid, Nehal F Farid, Basma H Anwar, Maimana A Magdy
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引用次数: 0

摘要

泼尼松龙(PDS)最近被用于治疗各种疾病,包括自身免疫性疾病和癌症。它还被用于治疗 2019 年冠状病毒感染相关的呼吸系统疾病。由于它可能诱发包括胃肠道病变和溃疡在内的健康问题,因此必须与埃索美拉唑(ESM)等其他药物同时使用,后者是一种质子泵拮抗剂,可降低溃疡发生的概率。因此,本研究的目标是创建一种环境安全、灵敏的高效液相色谱(HPLC)方法,用于测定 PDS 和 ESM 的二元组合和加标人体血浆。采用 C8 色谱柱(100 × 4.6 mm,5 μm)和梯度流动相洗脱,在 290 nm 波长下进行紫外识别,以分离所研究的药物。咖啡因作为内标物用于调整样品差异。血浆、咖啡因、ESM和PDS的tR值分别为1.4、3.5、6.3和7.3。采用绿色分析程序指数、分析绿色度量方法和分析生态尺度三种绿色评价工具对所建议方法的绿色特征进行了评价,结果表明该方法的绿色特征得到了认可和满足。根据美国 FDA 的建议对验证参数进行了评估,以满足全球对生物分析技术的要求,获得了可接受的限值。
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Development of HPLC-UV Method for Simultaneous Determination of Corticosteroid Co-Administered Immune Therapy.

Prednisolone (PDS) has recently been utilized to treat a variety of medical disorders, including autoimmune illnesses and cancer. It is also used to treat coronavirus disease 2019 infection-related respiratory problems. Because it may induce health problems including gastrointestinal lesions and ulceration, it has to be used alongside other drugs like esomeprazole (ESM), which acts as a proton pump antagonist to reduce the probability of ulceration. As a result, the goal of this research is to create an environmentally safe and sensitive high-performance liquid chromatography (HPLC) approach for determining PDS and ESM in their binary combination and spiked human plasma. C8 column (100 × 4.6 mm, 5 μm) and gradient mobile phase elution were used to separate the studied drugs with ultraviolet recognition at 290 nm. Caffeine was utilized as an internal standard to adjust the sample variance. Plasma, caffeine, ESM and PDS all had tR values of 1.4, 3.5, 6.3 and 7.3, respectively. The suggested method's greenness features were evaluated using three greenness evaluation tools: green analytical procedure index, analytical greenness metric approach and analytical eco-scale, and the findings were approved and satisfied. Validation parameters were evaluated in accordance with US-FDA recommendations in order to meet the global desires for biological analysis technique, acceptable limits were obtained.

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来源期刊
CiteScore
2.90
自引率
7.70%
发文量
94
审稿时长
5.6 months
期刊介绍: The Journal of Chromatographic Science is devoted to the dissemination of information concerning all methods of chromatographic analysis. The standard manuscript is a description of recent original research that covers any or all phases of a specific separation problem, principle, or method. Manuscripts which have a high degree of novelty and fundamental significance to the field of separation science are particularly encouraged. It is expected the authors will clearly state in the Introduction how their method compares in some markedly new and improved way to previous published related methods. Analytical performance characteristics of new methods including sensitivity, tested limits of detection or quantification, accuracy, precision, and specificity should be provided. Manuscripts which describe a straightforward extension of a known analytical method or an application to a previously analyzed and/or uncomplicated sample matrix will not normally be reviewed favorably. Manuscripts in which mass spectrometry is the dominant analytical method and chromatography is of marked secondary importance may be declined.
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