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首页> 外文期刊>Journal of Pharmaceutical Analysis >Determination of cefcapene acid by LC–MS and their application to a pharmacokinetic study in healthy Chinese volunteers
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Determination of cefcapene acid by LC–MS and their application to a pharmacokinetic study in healthy Chinese volunteers

机译：LC-MS法测定头孢卡因酸及其在中国健康志愿者体内药代动力学研究中的应用

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摘要

Simple, rapid and specific liquid chromatography–mass spectrometry (LC–MS) methods have been developed and validated for the quantification of cefcapene acid in human plasma and urine. Plasma samples were simply pretreated with methanol for deproteinization. Urine samples were briefly diluted with methanol–water (50:50, v/v), and centrifuged to remove large particles. Chromatographic separation was performed on a Hedera ODS-2 column. For the plasma assay, the isocratic mobile phase consisted of 35% solvent A (Methanol) and 65% solvent B (10mM ammonium acetate buffer solution containing 0.2% folic acid) with a flow rate of 0.3mL/min. For the urine assay, the isocratic mobile phase consisted of 30% solvent A (Methanol) and 70% solvent B (10mM ammonium acetate buffer solution containing 0.2% folic acid) with a flow rate of 0.3mL/min. The assays were linear over the concentration ranges of 0.03–5μg/mL in plasma and 0.1–400μg/mL in urine, and were successfully applied to a pharmacokinetic study after single and multiple oral administrations of cefcapene pivoxil hydrochloride tablets in healthy Chinese volunteers.
机译：已经开发了简单，快速，特异性的液相色谱-质谱（LC-MS）方法，并已用于定量测定人血浆和尿液中的头孢烯酸。血浆样品只需用甲醇预处理即可脱蛋白。尿液样品用甲醇-水（50:50，v / v）短暂稀释，然后离心去除大颗粒。在Hedera ODS-2色谱柱上进行色谱分离。对于血浆测定，等度流动相由35％的溶剂A（甲醇）和65％的溶剂B（含0.2％叶酸的10mM乙酸铵缓冲溶液）组成，流速为0.3mL / min。对于尿液测定，等度流动相由30％的溶剂A（甲醇）和70％的溶剂B（含0.2％叶酸的10mM乙酸铵缓冲溶液）组成，流速为0.3mL / min。该测定在血浆中0.03–5μg / mL和尿液中0.1–400μg / mL的浓度范围内呈线性关系，并且在健康的中国志愿者中一次或多次口服盐酸头孢哌酮匹伏昔片后成功地用于药代动力学研究。

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