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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
Author(s) -
Moreira Roberto F.,
Salvadori Myriam C.,
Azevedo Cristina P.,
OliveiraSilva Diogo,
Borges Diego C.,
Moreno Ronílson A.,
Sverdloff Carlos E.,
Borges Ney C.
Publication year - 2010
Publication title -
biomedical chromatography
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.4
H-Index - 65
eISSN - 1099-0801
pISSN - 0269-3879
DOI - 10.1002/bmc.1431
Subject(s) - chemistry , chromatography , bioavailability , human plasma , ondansetron , pharmacology , nausea , medicine
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 (CI) 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 0– t . Based on the 90% confidence interval of the individual ratios (test formulation/reference formulation) for C max and AUC 0‐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 © 2010 John Wiley & Sons, Ltd.