摘要
目的:建立适用于临床雷贝拉唑钠血药浓度监测的反相高效液相色谱测定方法。方法色谱柱:Agilent C18柱(4.6 mm ×250 mm,5μm),流动相:50 mmol· L-1磷酸二氢钾水溶液-乙腈=60∶40,流速:1.0 mL· min-1,紫外检测波长:288 nm。取血浆样品500μL,以卡马西平为内标,用乙腈沉淀蛋白后,直接取上清液20μL进行HPLC测定。考察该方法的专属性、标准曲线和定量下限、精密度与回收率、稳定性。结果雷贝拉唑线性范围为12.5~800.0 ng· mL-1,方法回收率为99.51%~104.08%,提取回收率为72.56%~77.97%,日内和日间的精密度均小于9.23%。结论本法较已有的方法更为简便、快速、准确,重现性好,符合临床血药浓度监测的要求。
Objective To develop a reverse phase high -performance liquid chromatography method for the determination of rabeprazole sodium in human plasma for therapeutic drug monitoring.Methods Chromatog-raphy was performed on Agilent C18 column ( 250 mm ×4.6 mm, 5μm) .The mobile phase consisted of 50 mmol · L-1 potassium dihydro-gen phosphate solution -acetonitrile ( 60∶40 ) at the flow rate of 1.0 mL· min -1 and UV detection wavelength is 288 nm.Carbamazepine was used as the internal standard.Plasma samples were extracted by acetoni-trile and then supernatant 20μL were determined by HPLC method.The specificity, standard curve and lower limit of quantification, accuracy rate and recovery rate as well as stability were investigated.Results Calibration curves were linear over the concentration range of 12.5 to 800ng· mL-1.The method recovery rate was 99.51% to 104.08% and theextraction recovery was 72.56% to 77.97%.The intra -day and inter -day RSD were both less than 9.23%.Conclusion The establishedHPLC method is simple, accurate, sensitive, and can be applied for thedetermination of rabeprazole sodium concentration in human plasma fortherapeutic drug monitoring.
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2015年第9期751-753,共3页
The Chinese Journal of Clinical Pharmacology
基金
无锡市科技发展指导性计划(社会发展)基金资助项目(CSZ00N1138)
关键词
雷贝拉唑钠
反相高效液相色谱
血药浓度监测
rabeprazole sodium
high-performance liquid chromatogra-phy
therapeutic drug monitoring