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Hernández, J. et al.

Hernández, Marcelín-Jiménez, Rivera, Alionka, Contreras, Hinojosa, Martínez-Rossier, Amancio, Fernández,

Development of an HPLC method for determination of diphenidol in plasma and its application in an oral multi-dose bioequivalence study in a healthy female Mexican population.

Diphenidol was determined by an HPLC method developed in our laboratory. It was validated and proved to be linear in the 40-400 ng/ml range. Accuracy for quality-control samples for intra and inter day assays ranged from 96.1-98.9% and 98.8-101.4%, respectively. This method was applied to a multi-dose bioequivalence study. No serious side effects were observed in the multi-dose design. Pharmacokinetic parameters (mean+/-standard error [S.E.]) of Cavg (ng/ml) and AUCtau (ngh/ml) for reference and test products were 139.54+/-12.66 versus 148.60+/-16.51 and 551.07+/-53.53 versus 588.78+/-69.02, respectively. Log-transformed values were compared by analysis of variance (ANOVA) followed by the classical 90% confidence interval (CI 90%) test and Schuirmann's test. Confidence limits ranged from 91.48-116.18% for Cmax and from 91.24-117.65% for AUCtau. These results suggest that the analytical method was linear, precise, and accurate for our purpose, and that both assayed formulations were bioequivalent.[1]

References

Development of an HPLC method for determination of diphenidol in plasma and its application in an oral multi-dose bioequivalence study in a healthy female Mexican population. Hernández, J., Marcelín-Jiménez, G., Rivera, L., Alionka, P.A., Contreras, L., Hinojosa, M., Martínez-Rossier, L., Amancio, O., Fernández, A. Journal of pharmaceutical and biomedical analysis. (2005) [Pubmed]

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