Glycerol-Based Green RP-HPLC Method for Simultaneous Determination of Methionine and Paracetamol in Pharmaceutical Tablets

IF 1.2 4区化学 Q4 BIOCHEMICAL RESEARCH METHODS Chromatographia Pub Date : 2023-10-10 DOI:10.1007/s10337-023-04283-y

Ahmed Habib, Mokhtar M. Mabrouk, Marwa Fekry, Fotouh R. Mansour

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引用次数: 1

Abstract

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.

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甘油绿色RP-HPLC法同时测定片剂中蛋氨酸和对乙酰氨基酚的含量

甲硫氨酸和对乙酰氨基酚以剂量形式结合，因为甲硫氨酸能够补偿肝脏患者谷胱甘肽的缺乏。在这项工作中，首次开发了一种创新的简单、省时的绿色RP-HPLC方法，使用甘油作为唯一的绿色流动相，用水同时测定其标准品和Hepamol®片剂中的甲硫氨酸和对乙酰氨基酚。色谱条件在Minitab 17®软件的帮助下使用析因设计进行优化。该方法在C18柱上于38°C下进行，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下进行。混合物在5分钟内分离。所开发的方法根据ICH要求进行了验证，两种药物的线性范围均为10-90μg/mL，蛋氨酸和扑热息痛的LOD均为3.33μg/mL。甘油具有高安全性、低紫外线截止点、低易燃性，并且在用水稀释时可以控制其粘度。将该方法与已报道的反相液相色谱法在绿色性、绿色分析程序指数和分析生态尺度方面进行了比较。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的天地。

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来源期刊

Chromatographia 化学-分析化学

CiteScore

3.40

自引率

5.90%

发文量

103

审稿时长

2.2 months

期刊介绍： Separation sciences, in all their various forms such as chromatography, field-flow fractionation, and electrophoresis, provide some of the most powerful techniques in analytical chemistry and are applied within a number of important application areas, including archaeology, biotechnology, clinical, environmental, food, medical, petroleum, pharmaceutical, polymer and biopolymer research. Beyond serving analytical purposes, separation techniques are also used for preparative and process-scale applications. The scope and power of separation sciences is significantly extended by combination with spectroscopic detection methods (e.g., laser-based approaches, nuclear-magnetic resonance, Raman, chemiluminescence) and particularly, mass spectrometry, to create hyphenated techniques. In addition to exciting new developments in chromatography, such as ultra high-pressure systems, multidimensional separations, and high-temperature approaches, there have also been great advances in hybrid methods combining chromatography and electro-based separations, especially on the micro- and nanoscale. Integrated biological procedures (e.g., enzymatic, immunological, receptor-based assays) can also be part of the overall analytical process.