A LC-MS/MS method for determination of stavudine in human plasma was established and validated, and it was applied to the\npharmaceutical formulations bioequivalence study. 0.5mL plasma sample was extracted by liquid-liquid extraction. Stavudine\nwas detected by a LC-MS/MS system. The pharmacokinetic parameters of stavudine in different formulations were calculated by\nnoncompartmentmodel statistics.Themethod was linear over the concentration ranges 5.00ââ?¬â??1000 ng/mL in plasma.Theintra- and\ninterassay relative standard deviation (RSD) was <10%. The average accuracies for the assay at three concentrations (5.00, 80.0, and\n900 ng/mL) were from100.2% to 102.5%. Pharmacokinetic parameters of stavudine reference formulation were obtained as follows:\n????max was 0.6 Ã?± 0.2 h, ????max was 480.7 Ã?± 150.9 g/L, t1/2 was 1.7 Ã?± 0.4 h, and AUC0????? was 872.8 Ã?± 227.8 g?h/L, and pharmacokinetic\nparameters of stavudine test formulationwere obtained as follows: ????max was 0.5Ã?±0.2 h, ????max was 537.5Ã?±178.5 g/L, t1/2 was 1.7Ã?±0.3 h,\nand AUC0????? was (914.1 Ã?± 284.5) g?h/L. Calculated with AUC0?????, the bioavailability of two formulations was 105.0%.
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