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.
Hernández
José
J
Servicio de Investigación de Farmacología Clínica, Unidad Analítica (405-E), Hospital General de México, Dr. Balmis #148, Col. Doctores, 06726 México, D.F., México. jhernanmex@netscape.net
Marcelín-Jiménez
G
G
Rivera
L
L
Alionka
P Angeles
PA
Contreras
L
L
Hinojosa
M
M
Martínez-Rossier
L
L
Amancio
O
O
Fernández
A
A
D000328:Adult; D000932:Antiemetics / Q000097:blood*; D002851:Chromatography, High Pressure Liquid; D003627:Data Interpretation, Statistical; D005260:Female; D006801:Humans; D008800:Mexico; D010880:Piperidines / Q000097:blood*; D015203:Reproducibility of Results; D013056:Spectrophotometry, Ultraviolet; D013810:Therapeutic Equivalency
D000932:Antiemetics; D010880:Piperidines; C004858:diphenidol