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 José

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Título :	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
Creador:	Hernández José
Nivel de acceso:	Open access
Palabras clave :	Cromatografía Líquida de Alta Presión - métodos Difenidol farmacocinética Mujer México Chromatography, High Pressure Liquid - Methods Diphenidol - Pharmacokinetics Female Mexico Diphenidol farmacocinética HPLC de fase inversa Ensayo clínico de dosis múltiples Diphenidol pharmacokinetics Reversed-phase HPLC Multi-dose clinical trial
Descripción :	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 (ng h/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
Colaborador(es) u otros Autores:	Marcelín Jiménez G Rivera L Alionka PA Contreras L Hinojosa M Martínez-Rossier L Amancio O Fernández A.Marcelín-Jimenez L. Rivera P. Angeles Alionka L. Contreras M. Hinojosa L. Martínez-Rossier O. Amancio A. Fernandez
Fecha de publicación :	2005
Tipo de publicación:	Artículo
Formato:	pdf
Identificador del Recurso :	http://dx.doi.org/10.1016/j.jpba.2005.01.037
Fuente:	J Pharm Biomed Anal 38(4):746-750
URI :	http://repositorio.pediatria.gob.mx:8180/handle/20.500.12103/2275
Idioma:	eng
Aparece en las colecciones:	Artículos

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