Pharmacokinetics/pharmacodynamics is the foundation for guiding the rational application of antibiotics in clinical practice, so it is necessary to establish quantitative methods for accurate drug concentration determination. This study aimed to develop a rapid and simple ultrahigh-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) method for simultaneous quantification of 14 antibiotics (amikacin, etimicin, ceftazidime, cefepime, cefoperazone, ceftriaxone, daptomycin, latamoxef, linezolid, meropenem, biapenem, ampicillin, norvancomycin, and vancomycin) in human plasma and cerebrospinal fluid. Antibiotics were chromatographically separated on a Waters ACQUITY UPLC BEH C18 column (2.1 mm × 50 mm, 1.7 μm) via gradient elution within 3 minutes and were monitored using positive ion fitted with multiple reaction monitoring. The lower limit of quantification was 0.05–2.0 μg·mL⁻¹. The method was verified according to the FDA bioanalysis method validation guidelines, which showed excellent accuracy (from 86.75% to 110.85%) and precision (from 0.46% to 10.97%). At last, this method was successfully applied to therapeutic drug monitoring in 113 patients under antibiotics treatment.

中文翻译：

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UPLC-MS/MS 方法同时测定人血浆和脑脊液中 14 种抗菌素：在治疗药物监测中的应用

药代动力学/药效学是指导抗生素在临床上合理应用的基础，因此有必要建立准确的药物浓度测定的定量方法。本研究旨在开发一种快速简便的超高效液相色谱-串联质谱 (UPLC-MS/MS) 方法，用于同时定量 14 种抗生素（阿米卡星、依替米星、头孢他啶、头孢吡肟、头孢哌酮、头孢曲松、达托霉素、拉他头孢、利奈唑胺） 、美罗培南、比阿培南、氨苄青霉素、去甲万古霉素和万古霉素）在人血浆和脑脊液中。抗生素在 Waters ACQUITY UPLC BEH C18 色谱柱（2.1 mm × 50 mm，1.7  μm) 在 3 分钟内通过梯度洗脱，并使用配备多反应监测的正离子进行监测。定量下限为0.05-2.0  μ g·mL ^-1。该方法根据 FDA 生物分析方法验证指南进行验证，显示出出色的准确度（从 86.75% 到 110.85%）和精密度（从 0.46% 到 10.97%）。最后，该方法成功应用于113例抗生素治疗患者的治疗药物监测。