CAJ | 학술논문

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。
목적：건립괄용우림상뢰패랍서납혈약농도감측적반상고효액상색보측정방법。방법색보주：Agilent C18주（4.6 mm ×250 mm，5μm），류동상：50 mmol· L－1린산이경갑수용액－을정＝60∶40，류속：1.0 mL· min－1，자외검측파장：288 nm。취혈장양품500μL，이잡마서평위내표，용을정침정단백후，직접취상청액20μL진행HPLC측정。고찰해방법적전속성、표준곡선화정량하한、정밀도여회수솔、은정성。결과뢰패랍서선성범위위12.5～800.0 ng· mL－1，방법회수솔위99.51％～104.08％，제취회수솔위72.56％～77.97％，일내화일간적정밀도균소우9.23％。결론본법교이유적방법경위간편、쾌속、준학，중현성호，부합림상혈약농도감측적요구。
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.