中国临床药学杂志2012，Vol.21Issue(1)：13-19,7.
LC-MS/MS法测定伊曲康唑的血浆浓度及在生物等效性试验中的应用
Determination of itraconazole in hunan plasma by LC-MS/MS and its application to bioequivalence
陈伟力 1许剑安 1汪红 1徐红蓉 1储楠楠 1申润钢 2张小林 3李雪宁1
作者信息
- 1. 复旦大学附属中山医院新药临床中心,上海200032
- 2. 江苏省昆山双鹤同德堂连锁大药房有限责任公司,昆山215300
- 3. 中关冠科生物技术有限公司,太仓215400
- 折叠
摘要
Abstract
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.关键词
LC-MS/MS伊曲康唑血浆浓度生物等效性Key words
LC-MS/MS/itraconazole/plasma concentration/bioequivalence引用本文复制引用
陈伟力,许剑安,汪红,徐红蓉,储楠楠,申润钢,张小林,李雪宁..LC-MS/MS法测定伊曲康唑的血浆浓度及在生物等效性试验中的应用[J].中国临床药学杂志,2012,21(1):13-19,7.
