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一种可持续且绿色的 HPLC-PDA 技术,用于同时评估 COVID-19 后综合征合并用药的绿色度和白度。

A sustainable and green HPLC-PDA technique for the simultaneous estimation of Post-COVID-19 syndrome co-administered drugs with greenness and whiteness assessment.

机构信息

Analytical Chemistry Department, Faculty of Pharmacy, October University for Modern Sciences and Arts (MSA), 11787, 6th October City, Egypt.

Analytical Chemistry Department, Faculty of Pharmacy (Girls), Al-Azhar University, Nasr City, Cairo, Egypt.

出版信息

Sci Rep. 2024 Oct 31;14(1):26222. doi: 10.1038/s41598-024-75216-4.

Abstract

COVID-19 has been a growing global concern in the past four years. Several syndromes associated with this multi-organ viral infection have been observed since the outbreak. According to estimates, 10-15% of people with SARS-CoV- infection may have post-COVID-19 syndrome. Even months after infection, common residual signs and symptoms include myalgia, exhaustion, shortness of breath, rapid heartbeat, stroke, and memory and cognitive impairment which can negatively affect survivors' quality of life and may consequently lead to their death. Therefore, it is necessary to think about potential therapy options for dealing with both short and long-term impacts. Paracetamol (a common analgesic and antipyretic) and Dexketoprofen Trometamol (a non-steroidal anti-inflammatory drug) are used together to relieve post-COVID symptoms like myalgia (muscle pain) and headache. Additionally, to prevent thrombotic events, Rivaroxaban is recommended for 35 days following discharge. Thus an eco-friendly HPLC-DAD technique was developed for simultaneous quantification of Paracetamol, Dexketoprofen Trometamol, and Rivaroxaban which are co-administered for treatment of post-COVID-19 syndrome. The suggested method was found to be linear in the concentration ranges of 3.00-45.00 µg/mL, 0.5-50.00 µg/mL, and 0.15-20.00 µg/mL, and a limit of detection down to 0.531 µg/mL, 0.095 µg/mL and 0.047 µg/mL for Paracetamol, Dexketoprofen Trometamol and Rivaroxaban, respectively. This method was effectively used to quantify the studied drugs in their bulk powder and spiked human plasma with high percentage recoveries (96.55-99.46%). The suggested approach was validated per International Conference on Harmonization (ICH) requirements and found to be within the acceptable ranges. The method was developed using Green Analytical Chemistry (GAC) principles, with the solvents used and run time having a significant effect on the method's greenness. "Non-toxic" ethanol served as the organic modifier in the mobile phase, moreover, the total run time was 12 min making it suitable for the routine analysis of the mentioned drugs in plasma samples. To get a full image of the method's greenness profile; two most recent greenness assessment tools, the Green Analytical Procedure Index (GAPI), and the Analytical GREEnness metric (AGREE), were employed, with White Analytical Chemistry (WAC) principles proving its environmental safety.

摘要

COVID-19 在过去四年中一直是全球关注的焦点。自疫情爆发以来,已经观察到与这种多器官病毒感染相关的几种综合征。据估计,SARS-CoV-感染的 10-15%的人可能患有 COVID-19 后综合征。即使在感染后数月,常见的残留症状和体征包括肌痛、疲劳、呼吸急促、心跳过快、中风以及记忆和认知障碍,这些都会对幸存者的生活质量产生负面影响,并可能导致他们死亡。因此,有必要考虑针对短期和长期影响的潜在治疗选择。扑热息痛(一种常见的镇痛药和解热药)和右旋酮洛芬氨丁三醇(一种非甾体抗炎药)联合用于缓解 COVID-19 后综合征的肌痛(肌肉疼痛)和头痛等症状。此外,为了预防血栓事件,建议在出院后 35 天内使用利伐沙班。因此,开发了一种环保的 HPLC-DAD 技术,用于同时定量测定扑热息痛、右旋酮洛芬氨丁三醇和利伐沙班,这些药物联合用于治疗 COVID-19 后综合征。该方法在 3.00-45.00μg/mL、0.5-50.00μg/mL 和 0.15-20.00μg/mL 的浓度范围内被发现是线性的,检测限分别降至 0.531μg/mL、0.095μg/mL 和 0.047μg/mL,扑热息痛、右旋酮洛芬氨丁三醇和利伐沙班的分别。该方法有效地用于定量测定其散装粉末中的研究药物,并对人血浆中的药物进行了高回收率(96.55-99.46%)的加标测定。所提出的方法符合国际人用药品注册技术协调会(ICH)的要求,并且在可接受的范围内。该方法是根据绿色分析化学(GAC)原理开发的,所用溶剂和运行时间对方法的绿色度有显著影响。无毒乙醇在流动相中用作有机改性剂,此外,总运行时间为 12 分钟,使其适用于血浆样品中所述药物的常规分析。为了全面了解该方法的绿色特性,使用了两种最新的绿色度评估工具,即绿色分析程序指数(GAPI)和分析绿色度指标(AGREE),并证明了白分析化学(WAC)原理的环境安全性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e844/11528028/9b06867dc8b0/41598_2024_75216_Fig1_HTML.jpg

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