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Glycerol-Based Green RP-HPLC Method for Simultaneous Determination of Methionine and Paracetamol in Pharmaceutical Tablets
Chromatographia ( IF 1.7 ) Pub Date : 2023-10-10 , DOI: 10.1007/s10337-023-04283-y
Ahmed Habib , Mokhtar M. Mabrouk , Marwa Fekry , Fotouh R. Mansour

Methionine and paracetamol are combined in dosage forms due to the ability of methionine to compensate the deficiency in glutathione in hepatic patients. In this work, an innovative simple time-saving green RP-HPLC method using glycerol as a solely green mobile phase with water for the first time was developed for the simultaneous determination of methionine and paracetamol in their standard and in Hepamol® tablets. The chromatographic conditions were optimized using factorial design with the aid of Minitab 17® Software. The method was performed on a C18 column at 38 °C, and a mobile phase consisting of glycerol and phosphate buffer (pH 2.4) (40:60, v/v), using diode array detector at 210 nm. The mixture was separated in 5 min. The developed method was validated in accordance with ICH requirement over linearity ranges of 10–90 μg/mL for both drugs, and LODs were 3.33 μg/mL for both methionine and paracetamol. Glycerol has high safety, low UV cut-off point, low flammability, and its viscosity can be manipulated when diluted with water. The procedure was compared to the reported reversed phase liquid chromatography method in the terms of their greenness with the green analytical procedure index and the analytical eco-scale. This work breaks new ground for scientists to use glycerol in greener RP-HPLC applications.



中文翻译:

甘油基绿色反相高效液相色谱法同时测定药片中蛋氨酸和扑热息痛

由于蛋氨酸能够补偿肝脏患者谷胱甘肽的缺乏,因此蛋氨酸和扑热息痛以剂型组合。在这项工作中,首次开发了一种创新、简单、省时的绿色 RP-HPLC 方法,首次使用甘油作为纯绿色流动相和水,用于同时测定标准品和 Hepamol® 片剂中的蛋氨酸和扑热息痛。借助 Minitab 17® 软件,使用因子设计优化色谱条件。该方法在 38 °C 的 C18 柱上进行,流动相由甘油和磷酸盐缓冲液 (pH 2.4) (40:60,v/v) 组成,使用二极管阵列检测器在 210 nm 处进行。5分钟内分离混合物。所开发的方法根据 ICH 要求在两种药物的 10-90 μg/mL 线性范围内进行了验证,蛋氨酸和扑热息痛的 LOD 均为 3.33 μg/mL。甘油安全性高、紫外线截止点低、可燃性低,用水稀释后可以控制其粘度。该程序与已报道的反相液相色谱法在绿色度、绿色分析程序指数和分析生态规模方面进行了比较。这项工作为科学家在更环保的 RP-HPLC 应用中使用甘油开辟了新天地。

更新日期:2023-10-12
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