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《Chinese Journal of Clinical Pharmacy》 2012-01
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Determination of itraconazole in human plasma by LC-MS/MS and its application to bioequivalence

CHEN Weili1,XU Jianan1,WANG Hong1,XU Hongrong1,CHU Nannan1,SHEN Rungang2,ZHANG Xiaolin3,LI Xuening1(1Clinical Trials Center,Zhongshan Hospital,Fudan University,Shanghai 200032,China;2Shuanghe Tongdetang Pharmacy Co.,Ltd.,Kunshan 215300,China;3Crown Bioscience Inc.,Taicang 215400,China)  
AIM To develop a LC-MS/MS method for determining itraconazole in human plasma and evaluate the bioequivalence of test formulation and reference formulation of itraconazole.METHODS The solvent system served as a protein precipitation reagent.The chromatographic separation was achieved on a CAPCELL PAK C18 column.The mobile phase consisted of acetonitrile,water and formic acid(75∶25∶0.15,V/V/V) and the flow rate was 0.20 mL·min-1.Detection was carried out on API 3000 using positive electrospray ion source and multiple reaction monitoring scan mode.RESULTS The linear calibration curve was in a range of 2-500 μg·L-1 with a limit of quantitation of 2 μg·L-1.The relative standard deviation(RSD) of inter-and intra-batch precision was less than 10%.The relative bioavailability of the test drug compared with reference drug was(112.71±59.58)%.CONCLUSION The method is proved to be accurate,rapid and sensitive enough to be successfully applied to a pharmacokinetic and bioequivalent study.The result shows that test and reference formulations are bioequivalent.
【CateGory Index】: R96
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