TLC densitometric approach for concurrent determination of quinary mixture for treatment of migraine with appraisal to method greenness and whiteness.

IF 3.8 2区综合性期刊 Q1 MULTIDISCIPLINARY SCIENCES

Scientific Reports Pub Date : 2024-12-16 DOI:10.1038/s41598-024-79518-5

Marco M Z Sharkawi, Marwa A Ahmed, Nehal F Farid, Nada S Abdelwahab

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Abstract

A new accurate, precise thin layer chromatographic (TLC densitometric) approach was developed for the simultaneous analysis of ergotamine tartrate (ERG), phenobarbital sodium (PHEN), caffeine anhydrous (CAF), dipyrone sodium (DIP) and meprobamate (MEP) in their pure form and in their combined formulation; (MIGRANIL tablets). TLC separation depended on using a stationary phase of TLC plates F₂₅₄ (20 × 10 cm) and using a developing system of ethyl acetate: methanol: n- hexane (8:2:3, by volume) with UV scanning at 254 nm for ERG, PHEN, CAF and DIP. For MEP, detection was done at 560 nm after spraying with 0.3% ethanolic solution of para -dimethylaminobenzaldehyde (PDAB) and heating at 110 ºC for 30 min. Analysis was performed in the concentration intervals of 0.06-2, 0.15-5 µg/band for ERG and PHEN, respectively; while for CAF, DIP and MEP it was done in the ranges of 0.3-9, 0.5-10, 1-100 µg/band, respectively. Moreover, the method was used for the quantitation of the five studied drugs in their unique formulation and the recovery% was calculated and found to be 102.04, 100.73, 100.65, 99.91, 1nd 101.77% for ERG, PHEN, CAF, DIP, and MEP, in order and all these outcomes proved excellent selectivity of the method. Other validation parameters were tested following ICH guidelines. Accuracy ranged from 98.02 to 100.53% while the obtained %RSD of interday day precision ranged from 1.215 to 1.940%. The environmental impact and performance of the method was tested with several tools; Analytical eco-scale, green analytical procedure index (GAPI), Analytical GREEnness Metric Approach (AGREE), Blue applicability grade index (BAGI), and RGB additive color model. Results ensured minimum hazardous effect on health and environment. This is the first analytical approach developed for simultaneous analysis of the quinary mixture which can be easily applied in any analytical laboratory.

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用 TLC 密度计法同时测定治疗偏头痛的二元混合物，并评估方法的绿色度和白色度。

为同时分析酒石酸麦角胺 (ERG)、苯巴比妥钠 (PHEN)、无水咖啡因 (CAF)、二吡喃酮钠 (DIP) 和甲丙氨酯 (MEP) 的纯品和复方制剂 (MIGRANIL 片剂) 开发了一种新的准确、精确的薄层色谱（TLC 密度计）方法。采用 F254 TLC 板（20 × 10 厘米）固定相和乙酸乙酯：甲醇：正己烷（8:2:3，体积比）显影系统进行 TLC 分离，在 254 纳米波长下对 ERG、PHEN、CAF 和 DIP 进行紫外线扫描。对于 MEP，在喷洒 0.3%的对二甲氨基苯甲醛（PDAB）乙醇溶液并在 110 ºC 下加热 30 分钟后，在 560 nm 波长下进行检测。对 ERG 和 PHEN 的分析浓度范围分别为 0.06-2、0.15-5 µg/带；对 CAF、DIP 和 MEP 的分析浓度范围分别为 0.3-9、0.5-10、1-100 µg/带。此外，该方法还用于对所研究的五种药物的独特配方进行定量，经计算发现，ERG、PHEN、CAF、DIP和MEP的回收率依次为102.04%、100.73%、100.65%、99.91%和101.77%，所有这些结果都证明了该方法具有极佳的选择性。其他验证参数按照 ICH 指南进行了测试。准确度为 98.02% 至 100.53%，日间精密度的 %RSD 为 1.215% 至 1.940%。该方法的环境影响和性能测试采用了多种工具：分析生态尺度、绿色分析程序指数（GAPI）、分析 GREEnness 度量方法（AGREE）、蓝色适用性等级指数（BAGI）和 RGB 添色模型。结果确保对健康和环境的有害影响降到最低。这是首个为同时分析二元混合物而开发的分析方法，可轻松应用于任何分析实验室。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Scientific Reports Natural Science Disciplines-

CiteScore

7.50

自引率

4.30%

发文量

19567

审稿时长

3.9 months

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