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Hydrophilic Interaction Liquid Chromatography-Electrospray Ionization Mass Spectrometry for Therapeutic Drug Monitoring of Metformin and Rosuvastatin in Human Plasma

机译:亲水性相互作用液相色谱 - 电喷雾电离质谱法用于二甲双胍和罗苏伐他汀在人血浆中的治疗药物监测

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摘要

In this work a hydrophilic interaction liquid chromatography/positive ion electrospray mass spectrometric assay (HILIC/ESI-MS) has been developed and fully validated for the quantitation of metformin and rosuvastatin in human plasma. Sample preparation involved the use of 100 μL of human plasma, following protein precipitation and filtration. Metformin, rosuvastatin and 4-[2-(propylamino) ethyl] indoline 2 one hydrochloride (internal standard) were separated by using an X-Bridge-HILIC BEH analytical column (150.0 × 2.1 mm i.d., particle size 3.5 μm) with isocratic elution. A mobile phase consisting of 12% (v/v) 15 mM ammonium formate water solution in acetonitrile was used for the separation and pumped at a flow rate of 0.25 mL min−1. The linear range of the assay was 100 to 5000 ng mL−1 and 2 to 100 ng mL−1 for metformin and rosuvastatin, respectively. The current HILIC-ESI/MS method allows for the accurate and precise quantitation of metformin and rosuvastatin in human plasma with a simple sample preparation and a short a chromatographic run time (less than 15 min). Plasma samples from eight patients were further analysed proving the capability of the proposed method to support a wide range of clinical studies.
机译:在这项工作中,已经开发了亲水性相互作用液相色谱/正离子电喷雾质谱法测定(HILIC / ESI-MS)并完全验证了人血浆中二甲双胍和罗苏伐他汀的定量。样品制备涉及使用100μl人血浆,后蛋白质沉淀和过滤。二甲双胍,罗苏伐他汀和4- [2-(丙基氨基)乙基]吲哚吲哚2一种盐酸吲哚(内标)分离,通过使用X-Bridg-Hilic BEH分析柱(150.0×2.1mm ID,粒径3.5μm),具有等物洗脱。将由乙腈中的12%(v / v)15mM甲酸铵水溶液组成的流动相用于分离并以0.25mL min-1的流速泵送。测定的线性范围分别为二甲双胍和罗苏伐他汀的100至5000ng ml-1和2至100ng ml-1。目前的HILIC-ESI / MS方法允许通过简单的样品制备和短的色谱研发时间(小于15分钟)来准确和精确地定量人血浆中的二甲双胍和罗萨杨蛋白。进一步分析了来自8名患者的血浆样品,证明了该方法支持各种临床研究的能力。

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