中国临床药学杂志2025，Vol.34Issue(10)：778-783,6.DOI:10.19577/j.1007-4406.2025.10.010
HPLC测定人血浆中替加环素浓度及其在治疗药物监测中的应用
HPLC for quantifying tigecycline in human plasma and its application in therapeutic drug monitoring
摘要
Abstract
AIM To establish a high performance liquid chromatography(HPLC)method for determining the concentration of tigecycline in human plasma,and apply it to clinical therapeutic drug monitoring(TDM).METHODS The analytical column used was a C18 column,with a mobile phase that consisted of a gradient of methanol and phosphoric acid buffer at pH 3.2.Detection was performed at 346 nm with a flow rate of 1.0 mL·min-1.The column temperature was maintained at 35℃,and 40 μL of sample was injected into the HPLC system for analysis.The plasma sample was deproteinized using perchloric acid and acetonitrile method.The established method was applied to a TDM case of tigecycline.The concentrations of tigecycline in human plasma at 3 time points(1.5,6,and 11.5 h after administration)were measured.The area under the concentration-time curve(AUC0-24 h)was calculated through the linear trapezoidal method,and the pharmacokinetic/pharmacodynamic(PK/PD)parameter AUIC(AUIC=AUC0-24 h/MIC)was subsequently determined.RESULTS The HPLC method established in the study successfully separated tigecycline from other components in human plasma.It demonstrated good linearity within the plasma concentration range of 0.05 to 5.00 μg·mL-1,with both intra-day and inter-day relative standard deviations(RSD)meeting the required criteria.Good stability of the plasma samples was observed under different conditions.The results of applying the HPLC method to clinical TDM showed that the patient's AUC0-24hwas 9.43 μg·h·mL-1 and the AUIC was 4.72 h after adjusting the tigecycline dosing regimen.CONCLUSION The established HPLC analytic method for determining tigecycline concentration in human plasma is simple to operate,highly specific,and exhibits minimal interference.The standardized protocol for tigecycline TDM based on the HPLC technique provides a reliable basis for designing individualized dosing regimens.关键词
替加环素/血浆/高效液相色谱法/治疗药物监测/个体化用药指导Key words
tigecycline/plasma/high performance liquid chromatography/therapeutic drug monitoring/individualized medication guidance分类
药学引用本文复制引用
黄金路,万丽丽,李婕,周纯熙,杨黎,卢进,崔慧昕,张铮亦,胡佳璐,郭澄..HPLC测定人血浆中替加环素浓度及其在治疗药物监测中的应用[J].中国临床药学杂志,2025,34(10):778-783,6.基金项目
上海市临床药学重点专科建设项目(编号AB83110002016007) （编号AB83110002016007）
上海市第六人民医院医院管理院级科研专项(编号Lyg1202304) （编号Lyg1202304）
上海市第六人民医院医学教育研究课题(编号LYBKYB202304) （编号LYBKYB202304）
