Green UHPLC Method for Simultaneous Determination of Febuxostat and Diclofenac in Pharmaceutical Dosage Form and Human Plasma

S. A. Mahmoud, A. El-Kosasy, Fatma A. Fouad
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引用次数: 3

Abstract

Eco-friendly Ultra-high-performance liquid chromatography (UHPLC) with green aqueous-organic mobile phase was applied for the simultaneous determination of febuxostat (FEB) and diclofenac (DIC) with the composition of water:ethanol (85:15 v/v) utilizing phenomenex Kinetex C 18 column (4.6 × 100 mm 2.6 µm), flow rate 1 ml/min and UV detection at 280 nm with linear ranges of 0.4 - 4.0 μg/mL and 0.5 - 5.0 μg/mL for FEB and DIC, respectively. The proposed method was also successfully applied to analyze the two drugs in pharmaceutical dosage form and human plasma. The results obtained were validated and statistically analyzed and found to be in accordance with those given by reported methods. Moreover, the greenness of the developed method is assessed using suitable analytical Eco-Scale and GAPI tools and comparison with the previously published methods have been carried out to indicate the priority of the proposed method. UHPLC is considered eco- friendly method regarding uses of safe solvents, simple, accurate and short time of analysis.
绿色高效液相色谱法同时测定药物剂型和人血浆中非布司他和双氯芬酸的含量
采用绿色水-有机流动相超高效液相色谱法(UHPLC)同时测定非布xostat (FEB)和双氯芬酸(DIC)(水:乙醇(85:15 v/v))的含量,色谱柱为phenomenex Kinetex C 18 (4.6 × 100 mm 2.6µm),流速为1 ml/min, 280 nm紫外检测波长,FEB和DIC的线性范围分别为0.4 ~ 4.0 μg/ ml和0.5 ~ 5.0 μg/ ml。该方法还成功地应用于两种药物的药物剂型和人血浆分析。对所得结果进行了验证和统计分析,发现与报告方法的结果一致。此外,使用合适的分析生态尺度和GAPI工具评估了所开发方法的绿色度,并与先前发表的方法进行了比较,以表明所提出方法的优先级。高效液相色谱法具有溶剂安全、简便、准确、分析时间短等优点。
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