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血浆中两种银屑病药物的环保薄层色谱法检测:一种绿色分析方法。

Eco-conscious TLC assay for dual psoriasis drugs in plasma: a green analytical approach.

作者信息

Magdy Maimana A, Anwar Basma H, Farid Nehal F, Abdelhamid Nessreen S

机构信息

Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Beni-Suef University, Alshaheed Shehata Ahmad Hegazy St., Beni-Suef, 62514, Egypt.

出版信息

BMC Chem. 2025 Jun 13;19(1):166. doi: 10.1186/s13065-025-01531-0.

Abstract

Psoriasis is one of the dermatological autoimmune diseases that involve cracking, redness, bleeding and inflammation on the surface of the skin. Sulfasalazine (SUL) is an immunity suppressing and anti-phlogistic drug. Pentoxifylline (PTN) is an immunosuppressant and vasodilator. So, the two drugs are co-administered together in the treatment protocol for psoriasis. No chromatographic analytical method was developed in the literature for the quantitative determination of SUL and PTN in their binary mixture and spiked human plasma. So, this work's goal is to establish an environmentally friendly and selective TLC method for quantitative assay of sulfasalazine and pentoxifylline in their common mixture and spiked human plasma samples. The separation was successfully obtained using a developing system consisting of ethanol: ethyl acetate (7: 3, v/v) and 270 nm as UV scanning wavelength. Paracetamol was chosen as an internal standard to correct sampling minute variations. The obtained retardation factor values were 0.02, 0.43, 0.68 and 0.8 for plasma, pentoxifylline, sulfasalazine and paracetamol, in the same order. The resulting LLOQ for SUL and PTN were 0.3 and 0.2 µg/band, respectively. Three environmental friendliness assessment tools including analytical greenness metric approach (AGREE), eco-scale assessments, and green analytical procedure index (GAPI) were applied to evaluate the environmental safety characters of the suggested method. Validation parameters were within the accepted ranges when checked according to US-FDA guidelines to for bioanalytical method validation.

摘要

银屑病是一种皮肤自身免疫性疾病,其症状包括皮肤表面出现干裂、发红、出血和炎症。柳氮磺胺吡啶(SUL)是一种免疫抑制和抗炎药物。己酮可可碱(PTN)是一种免疫抑制剂和血管扩张剂。因此,这两种药物在银屑病治疗方案中联合使用。文献中尚未开发出用于定量测定二元混合物和加标人血浆中SUL和PTN的色谱分析方法。因此,本研究的目的是建立一种环境友好且具有选择性的薄层色谱法,用于定量测定其常见混合物和加标人血浆样品中的柳氮磺胺吡啶和己酮可可碱。使用由乙醇:乙酸乙酯(7:3,v/v)组成的展开系统,并以270nm作为紫外扫描波长,成功实现了分离。选择对乙酰氨基酚作为内标以校正采样的微小变化。血浆、己酮可可碱、柳氮磺胺吡啶和对乙酰氨基酚的保留因子值依次为0.02、0.43、0.68和0.8。SUL和PTN的最低定量限分别为0.3和0.2μg/条带。应用包括分析绿色度指标法(AGREE)、生态规模评估和绿色分析程序指数(GAPI)在内的三种环境友好性评估工具,对所建议方法的环境安全性进行评估。根据美国食品药品监督管理局(US-FDA)生物分析方法验证指南进行检查时,验证参数在可接受范围内。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/60ae/12164079/1de80578a73c/13065_2025_1531_Fig1_HTML.jpg

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