Title: Determination of Zanamivir in Human Plasma by HPLC-MS/MS and Its Application to Pharmacokinetics Study
Abstract: Objective:To develop an HPLC-MS/MS method for the determination of zanamivir in human plasma and study pharmacokinetics in healthy volunteers. Methods:24volunteers were divided into two groups, with6 males and 6 females in each group in a two-period crossover design. After a two-period, randomized, crossover study of pharmacokinetics after single dose of 5,10mg zanamivir, with a interval of two weeks, the 12 volunteers took part in a study of pharmacokinetics after multiple doses of 5mg zanamivir. zanamivir in plasma was determined by LC-MS/MS method, and pharmacokinetics parameters were calculated by DAS 2.1.1 software. Results: The main pharmacokinetics parameters in the study after single dose of 5, 10mg zanamivir were as follows: tmax (4.083±0.996),(4.583±1.379) h; ρmax (4.482±1.25)(,9.171±3.888) μg·L-1; AUC(0-t) (110.725±31.766)(,234.926±85.631)μg·h·L-1;AUC(0-∞) (125.405±36.906),(267.029±105.504)μg·h·L-1; t1/2 (27.084±9.482),(26.167±5.749) h. And main pharmacokinetics parameters in multiple doses study were: tmax (4.25±1.288) h;ρmax (16.613±5.418) μg·L-1;AUC(0-t) (585.128±239.583) μg·h·L-1;AUC(0-∞) (697.610±311.242) μg·h·L-1;AUCSS (112.546±37.533) μg·h·L-1;t1/2 (29.958±9.842) h. Conclusion :The LC-MS/MS method was sensitive, accuracy and fast, which is suitable for the determination of zanamivir in human plasma. The pharmacokinetic parameters of zanamivir in healthy volunteers after oral single, multiple dose of zanamivir is concordant with that of the literature. There is no significant difference in the pharmacokinetic parameters between female and male subjects
Publication Year: 2010
Publication Date: 2010-01-01
Language: en
Type: article
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