摘要
目的:建立一种快速、灵敏、准确、稳定的测定人血清中伏立康唑药物浓度的方法,用于伏立康唑的治疗药物监测。方法:采用RP-HPLC法,色谱柱为InertsilODS-3,流动相为乙腈∶冰醋酸-三乙胺缓冲液(pH=6,45∶55,v/v),流速为1mL·min^(-1),检测波长255nm。结果:伏立康唑在0.097~23.380μg·mL^(-1)范围内线性关系良好(r=0.9990),定量下限为0.05μg·mL^(-1);低、中、高三个浓度血清样品日内、日间稳定性RSD分别为0.89%~4.15%和0.72%~4.22%;精密度RSD分别为0.89%~4.47%和0.72%~4.22%;冻融稳定性RSD为1.16%~8.42%;重复性RSD为0.12%~8.37%,低、中、高浓度提取回收率在98.59%~117.56%之间。结论:伏立康唑血药浓度个体差异大,对危重患者开展治疗药物监测,有助于提高临床疗效,减少不良反应的发生风险。本方法操作简便,结果准确,适用于临床中伏立康唑的治疗药物监测。
Objective:To develop a rapid,sensitive,accurate and stable method for the determination of voriconazole in human serum for therapeutic drug monitoring(TDM)of voriconazole.Methods:The sample was detected by RP-HPLC,and the column was inertsil ODS-3,the mobile phase consisted of acetonitrile and 0.01%of acetic acid-triethylamine buffer solution(pH=6,45∶55,v/v),flow rate was 1 mL·min^(-1),the detection wavelength was 255 nm.Results:The serum concentration of voriconazole was linear at the range of 0.097-23.380μg·mL^(-1)(r=0.9990).The lower limit of quantitation was 0.05μg·mL^(-1).The intra-day and inter-day relative standard deviations(RSD)of low-dose,middle-dose and high-dose of voriconazole were in the range of 0.89%-4.15%and 0.72%-4.22%respectively.Precision RSD of them were in the range of 0.89%-4.47%and 0.72%-4.22%respectively.RSD of freeze-thaw stability was in the range of 1.16%-8.42%.Repeatability RSD was in the range of 0.12%-8.37%.The recovery rates of the different concentration of voriconazole were in the range of 98.59%-117.56%.Conclusion:There were large individual differences in serum concentration of voriconazole,it is helpful to improve the clinical efficacy and reduce the risk of adverse reactions to carry out TDM for critically ill patients.This method was accurate and stable,which was suitable for the determination of voriconazole concentration in human serum.
作者
张文娟
姚瑶
强琼
杨乐
刘琳娜
ZHANG Wen-juan;YAO Yao;QIANG Qiong;YANG Le;LIU Lin-na(Department of Pharmacy,the Second Affiliated Hospital of PLA Air Force Medical University,Xi'an 710038,China)
出处
《中国药物应用与监测》
CAS
2021年第1期9-12,共4页
Chinese Journal of Drug Application and Monitoring
基金
陕西省重点研发计划项目(2020SF-213)。
关键词
伏立康唑
反相高效液相色谱法
治疗药物监测
Voriconazole
Reversed phase high performance liquid chromatography
Therapeutic drug monitoring
作者简介
通信作者:刘琳娜,女,副主任药师,主要从事临床药理学研究。E-mail:sunflower546@126.com;张文娟,女,主管药师,主要从事治疗药物监测工作。E-mail:zhangwenjuan4221@163.com。
