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| Titel: |
Cimetidine Quantification in Human Plasma by High-performance Liquid Chromatography Coupled to Electrospray Ionization Tandem Mass Spectrometry. Application to a Comparative Pharmacokinetics Study |
| Auteur: |
Moreno RA Oliveira CostaI Brum Junior L Sverdloff CE Domingues CC Borges DC Oliveira RA Borges NC |
| Verschenen in: |
Journal of bioanalysis & biomedicine |
| Paginering: | Jaargang 01 (2009) nr. 01 pagina's 005-013 |
| Jaar: |
2009 |
| Inhoud: |
<p>A specific, fast and sensitive LC–MS/MS assay was developedfor the determination of cimetidine in human plasma using nizatidine as the internal standard (IS). The limit of quantification was 5.0 ng/ml and the method was linear in the range of 5.0 to 5000 ng/ml. The cimetidine and IS retention times were 1.35±0.3 and 1.40±0.03 min,respectively. Method intra-batch precision and accuracy ranged from 2.0 to 5.4%, and 92.1 to 103.7%, respectively. Inter-batch precision ranged from 4.2 to 6.3%, while Inter- batch accuracy ranged from 97.0 to 106.6%.</p><p>The analytical method was applied to evaluate the pharmacokineticand relative bioavailability of two different pharmaceutical formulations containing 400 mg of cimetidine containing. This study evaluated 29 volunteers in a randomized, 2-period crossover study with 14 days washout period between doses. The geometric mean andrespective 90% CI of cimetidine test/reference percent ratios were 95.73% (87.76 - 104.43%) for Cmax, 100.80% (95.98 - 105.96%) for AUC0-t and 100.90 (96.06 - 105.88) for AUC0-inf. Based on the 90% confidence interval of the individual ratios (test formulation/reference formulation) for Cmax and AUC0-inf, it was concluded that the test formulation is bioequivalent to the reference one with respect to the rate and extent of absorption of cimetidine. In addition, using the Kruskal-Wallis Test no statistical differences of Tmax and the Cmax were observed related to the sex of the volunteer. |
| Uitgever: |
OMICS Publishing Group (provided by DOAJ) |
| Bronbestand: |
Elektronische Wetenschappelijke Tijdschriften |
Details van artikel 4 van 19 gevonden artikelen
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