四川大学学报（医学版）2018，Vol.49Issue(1)：107-112,6.
LC-MS/MS法测定人血浆中替诺福韦质量浓度及其生物等效性研究
LC-MS/MS Determination of Tenofovir in Human Plasma and Its Bioequivalence
陈枳潓 1冯仕银 2南峰 3余勤 2梁茂植3
作者信息
- 1. 四川大学华西药学院 成都610041
- 2. 四川大学华西医院国家药物临床试验机构·GCP中心 成都610041
- 3. 四川大学华西第二医院药物临床试验机构 成都610041
- 折叠
摘要
Abstract
Objective To develop a liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for detecting tenofovir in human plasma.Methods Twenty four healthy male volunteers received a single oral dose of 300 mg tenofovir disoproxil fumarate tablets under fasting and high-fat diet conditions in a randomized four-way crossover bioequivalence study with two preparations of tablets.Plasma samples were taken and analyzed using the LC-MS/MS method.The pharmacokinetic parameters of the two preparations were calculated and compared statistically to evaluate their bioequivalence using Phoenix Winnonlin6.3.Results Linear detection responses were obtained for tenofovir at the range from 3.13 to 500 ng/mL.The intra-and inter day precisions were high,with lower than 5.43 ％ [relative standard deviation (RSD)％],high recovery and good stability.The 90％ confidence intervals of peak concentration (Cmax) of tenofovir and its area under the curve (AUC0t and AUC0-∞) all fell within the bioequivalence limit 80.00％-125.00％ under both fasting and high-fat diet conditions.No significant difference in peak time (Tmax) was demonstrated between the two preparations (P＞0.05).Conclusion The LC-MS/MS method can be used for simultaneous determination of tenofovir in human plasma.The two preparations of tablets are bioequivalent.关键词
替诺福韦/液相色谱-串联质谱/生物等效性Key words
Tenofovir/LC-MS/MS/Bioequivalence引用本文复制引用
陈枳潓,冯仕银,南峰,余勤,梁茂植..LC-MS/MS法测定人血浆中替诺福韦质量浓度及其生物等效性研究[J].四川大学学报（医学版）,2018,49(1):107-112,6.
