High-throughput and wide-range simultaneous determination of linezolid, daptomycin and tedizolid in human plasma using ultra-performance liquid chromatography coupled to tandem mass spectrometry
High-throughput and wide-range simultaneous determination of linezolid, daptomycin and tedizolid in human plasma using ultra-performance liquid chromatography coupled to tandem mass spectrometry
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超高效液相色谱-串联质谱法高通量、宽范围同时测定人血浆中的利奈唑胺、达托霉素和泰地唑胺
DOI：
10.1016/j.jpba.2020.113764
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发表时间：
2021
影响因子：
3.4
通讯作者：
Itoh Hiroki
中科院分区：
文献类型：
--
作者：
Tanaka Ryota;Kai Makoto;Goto Koji;Ohchi Yoshifumi;Yasuda Norihisa;Tatsuta Ryosuke;Kitano Takaaki;Itoh Hiroki
最近几项关于利奈唑胺（LZD）和达托霉素（DAP）药代动力学的研究报告，血浆浓度与疗效和不良反应有关，表明治疗药物监测（TDM）的有用性。尚未报道TDM对替地唑胺（TZD）的有用性，但先前的报告显示曲线下面积的个体差异取决于体重。在重症监护室（ICU）患者中，据报告药代动力学因各种因素而波动。在这里，我们开发了一种高通量和宽范围的同时定量方法，LZD，DAP和TZD在人血浆中使用超高效液相色谱串联质谱（UPLC-MS/MS）。使用Oasis® HLB μ洗脱板通过固相萃取预处理血浆样品。该测定符合美国食品药品监督管理局和欧洲药品管理局对生物分析方法验证的要求。LZD、DAP和TZD的测定分别在100 - 100000、150 - 150000和5 - 5000 ng/mL的宽范围内显示出良好的线性。所有三种药物的批内准确度和精密度以及批间准确度和精密度均符合上述指南的标准。LZD、DAP和TZD的提取回收率分别大于92.2%、44.7%和84.8%。基质效应在低、中、高3种药物质控样品间无显著性差异。采用新型UPLC-MS/MS法测定了ICU中接受LZD、DAP或TZD治疗的3例患者的最大和谷浓度。在所有患者中，测得的浓度均在校准曲线的范围内，证明了新方法临床应用的可行性。总之，我们成功地开发了第一种同时定量LZD、DAP和TZD血浆浓度的方法。
Several recent studies on pharmacokinetics of linezolid (LZD) and daptomycin (DAP) reported that plasma concentration was linked to efficacy and adverse effects, suggesting the usefulness of therapeutic drug monitoring (TDM). The usefulness of TDM for tedizolid (TZD) has not been reported, but a previous report showed individual differences in area under the curve depending on body weight. In intensive care unit (ICU) patients, pharmacokinetics was reported to fluctuate due to various factors. Here, we developed a high-throughput and wide-range simultaneous quantification method for LZD, DAP and TZD in human plasma using ultra-performance liquid chromatography coupled to tandem mass spectrometry (UPLC-MS/MS). Plasma samples were pretreated by solid-phase extraction using Oasis® HLB μElution Plate. The assay fulfilled the requirements of US Food and Drug Administration and the European Medicines Agency for bioanalytical method validation. The assay for LZD, DAP and TZD showed good linearity over wide ranges of 100−100000, 150−150000 and 5−5000 ng/mL, respectively. Within-batch accuracy and precision as well as batch-to-batch accuracy and precision for all three drugs fulfilled the criteria of the above guidance. Extraction recovery rates were more than 92.2 % for LZD, 44.7 % for DAP, and 84.8 % for TZD. Matrix effect showed no remarkable differences among low, medium and high quality control samples for the three drugs. The maximum and trough concentrations of three patients each who received LZD, DAP or TZD in ICU were measured by the novel UPLC-MS/MS method. In all patients, the measured concentrations were within the ranges of the calibration curves, demonstrating the feasibility of clinical application of the novel method. In conclusion, we have succeeded to develop the first method for simultaneous quantification of plasma concentrations of LZD, DAP and TZD.