کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
10553701 | 967909 | 2005 | 5 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
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
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کلمات کلیدی
موضوعات مرتبط
مهندسی و علوم پایه
شیمی
شیمی آنالیزی یا شیمی تجزیه
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چکیده انگلیسی
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.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical and Biomedical Analysis - Volume 38, Issue 4, 15 July 2005, Pages 746-750
Journal: Journal of Pharmaceutical and Biomedical Analysis - Volume 38, Issue 4, 15 July 2005, Pages 746-750
نویسندگان
José Hernández, G. MarcelÃn-Jiménez, L. Rivera, P. Ángeles Alionka, L. Contreras, M. Hinojosa, L. MartÃnez-Rossier, O. Amancio, A. Fernández,