Liquid chromatography-tandem mass spectrometric assay for determination of stavudine in human plasma

A lc-ms/ms method for determination of stavudine in human plasma was established and validated,and it was applied to the pharmaceutical formulations bioequivalence study. 0.5 ml plasma sample was extracted by liquid-liquid extraction. stavudine was detected by a lc-ms/ms system. the pharmacokinetic parameters of stavudine in different formulations were calculated by noncompartment model statistics. the method was linear over the concentration ranges 5.00-1000 ng/ml in plasma. the intra- and interassay relative standard deviation (rsd) was <10%. the average accuracies for the assay at three concentrations (5.00,80.0,and 900 ng/ml) were from 100.2% to 102.5%. pharmacokinetic parameters of stavudine reference formulation were obtained as follows: t m a x was 0.6 ± 0.2 h,c m a x was 480.7 ± 150.9 g/l,t was 1.7 ± 0.4 h,and au c 0 - t was 872.8 ± 227.8 g·h/l,and pharmacokinetic parameters of stavudine test formulation were obtained as follows: t m a x was 0.5 ± 0.2 h,c m a x was 537.5 ± 178.5 g/l,t was 1.7 ± 0.3 h,and au c 0 - t was (914.1 ± 284.5) g·h/l. calculated with au c 0 - t,the bioavailability of two formulations was 105.0%. © 2014 fengdan jin.