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|Type:||Artigo de periódico|
|Title:||Development and validation of a rapid and sensitive LC-ESI-MS/MS method for ondansetron quantification in human plasma and its application in comparative bioavailability study|
|Abstract:||The validation of a high throughput and specific method using a high-performance liquid chromatography coupled to electrospray (ES+) ionization tandem triple quadrupole mass spectrometric (LC-ESI-MS/MS) method for ondansetron quantification in human plasma is described Human plasma samples were extracted by liquid-liquid extraction (LLE) using methyl tert-butyl ether and analyzed by LC-ESI-MS/MS The limit of quantification was 0 2 ng/mL and the method was linear in the range 0 2-60 ng/mL The intra-assay precisions ranged from 1 6 to 7 7%, while inter-assay precisions ranged from 2 1 to 5 1% The intra-assay accuracies ranged from 97 5 to 108 2%, and the inter-assay accuracies ranged from 97 3 to 107 0% The analytical method was applied to evaluate the relative bioavailability of two pharmaceutical formulations containing 8 mg of ondansetron each in 25 healthy volunteers using a randomized, two-period crossover design The geometric mean and respective 90% confidence interval (Cl) of ondansetron test/reference percent ratios were 90 15% (81 74-99 44%) for C(max) and 93 11% (83 01-104 43%) for AUC(o-t) Based on the 90% confidence interval of the individual ratios (test formulation/reference formulation) for C(max) and AUC(o-inf), , it was concluded that the test formulation is bioequivalent to the reference one with respect to the rate and extent of absorption of ondansetron Copyright (C) 2010 John Wiley & Sons, Ltd|
|Editor:||John Wiley & Sons Ltd|
|Appears in Collections:||Unicamp - Artigos e Outros Documentos|
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