摘要
目的建立HPLC-UV法测定人脑脊液中替考拉宁浓度,为颅内感染患者使用替考拉宁抗感染治疗和调整给药剂量提供依据。方法根据2015年版《中国药典》收载的生物样品定量分析方法验证指导原则,以富马酸喹硫平为内标,采用Welch Ultimate XB-C18(250 mm×4.6 mm,5 μm)色谱柱,在流动相为乙腈-0.01 mol·L-1磷酸二氢钠缓冲液(25.5∶74.5,v/v),柱温为35℃,流速为1.0 mL·min-1,检测波长为240 nm的条件下检测人脑脊液中替考拉宁的浓度。结果 人脑脊液中替考拉宁浓度在1.5625~100.0 μg·mL-1与峰面积成良好线性关系(r2=0.9998);替考拉宁检测限为0.3125 μg·mL-1。日内精密度RSD<4.1%,日间精密度RSD<4.9%,回收率为96.64%~103.22%。室温下放置24 h,冻融循环3次和-80℃冷冻30 d的稳定性均良好。结论所建立的方法简便、准确度高、特异性强,适用于临床人脑脊液中替考拉宁浓度的检测,可为颅内感染患者个体化、精准化给药治疗提供依据。
Objective To determine the concentration of teicoplanin in human cerebrospinal fluid,and provide a reference for patients with intracranial infection receiving teicoplanin anti-infection treatment and dosage adjustment by HPLC-UV method.Methods According to the verification guidelines for quantitative analysis of biological samples in the 2015 Chinese Pharmacopoeia,quetiapine fumarate was used as the internal standard.The separation was performed on Welch Ultimate XB-C18 column (250 mm×4.6 mm,5 μm) with a mobile phase consisting of acetonitrile and sodium dihydrogen phosphate (25.5∶74.5,v/v) at the flow rate of 1.0 mL·min-1.The column temperature was maintained at 35℃ and the detection wavelength was 240 nm.Results The sample of teicoplanin in human cerebrospinal fluid showed a good linearity at 1.5625~100.0 μg·mL-1 (r2=0.9998) and the detection limit of teicoplanin was 0.3125 μg·mL-1.The intra-day RSD was less than 4.1%,the inter-day RSD was less than 4.9%,and the recovery was 96.64%~103.22%.The sample of teicoplanin in human cerebrospinal fluid were all stable at room temperature for 24 h,repeated freezing and thawing for 3 times,and at -80℃ for 30 days.Conclusion The established method has good precision and accuracy,high sensitivity,and simple operation procedure.It is suitable for the detection of teicoplanin concentration in human cerebrospinal fluid,which provides reference for the individualized treatment for patients with intracranial infection.
作者
缪文清
范先煜
周利娟
范国荣
MIAO Wen-qing;FAN Xian-yu;ZHOU Li-juan;FAN Guo-rong(Department of Clinical Pharmacy,Shanghai General of Hospital,Shanghai Jiao Tong University,Shanghai 200080)
出处
《中南药学》
CAS
2020年第8期1339-1343,共5页
Central South Pharmacy
基金
国家自然科学基金项目(No.81703597)
上海市卫计委重要薄弱学科建设--临床药学(No.2016ZB0302)。
关键词
HPLC
脑脊液
替考拉宁
药物浓度
HPLC
cerebrospinal fluid
teicoplanin
drug concentration
作者简介
缪文清,男,硕士,主要从事临床药学和个体化治疗药物监测工作,E-mail:miaowq0619@163.com;通信作者:范国荣,男,博士,主任药师,主要从事临床药学和临床药代动力学研究,E-mail:guorfan@163.com。
