PMID: 11232858Mar 10, 2001Paper

Development of a high-performance liquid chromatographic method for bioequivalence study of flavoxate tablets

Journal of Chromatography. B, Biomedical Sciences and Applications
M T SheuH O Ho

Abstract

An improved HPLC method was developed for the concentration determination of the metabolite of flavoxate, 3-methyl-flavone-8-carboxylic acid (MFCA), in plasma in an attempt to compare two flavoxate tablet formulations. This HPLC method was validated by examining the precision and the accuracy for inter-day and intra-day runs in a linear concentration range of 0.1-24 microg/ml. The coefficients of variation (C.V.) of inter-day and intra-day assays were 0.24-7.18% and 0.06-5.70%, respectively. The standard errors of mean (S.E.M.) were -0.004-8.68% and -2.52-4.86% for inter-day and intra-day assays, respectively. Bioequivalence of the two formulations was determined on 12 normal healthy male volunteers in a single-dose, two-period, two-sequence, two-treatment crossover study. MFCA plasma concentrations were analyzed with this validated HPLC method. The normal pivotal parameters, AUC(0-last), AUC(0-inf) and Cmax, were calculated and compared using the SAS General Linear Model computer program. The two one-sided t distribution test was also performed, as well as the 90% confidence-interval method, for the mean difference of the three pivotal parameters. The results suggest that these two flavoxate tablet formulations are non-bioequi...Continue Reading

References

Aug 1, 1976·Pharmacological Research Communications·M BertoliI Setnikar
Jun 1, 1960·Journal of Medicinal and Pharmaceutical Chemistry·P DA REI SETNIKAR

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Citations

Nov 11, 2003·Clinical Pharmacokinetics·David R P Guay
Nov 3, 2010·Journal of Young Pharmacists : JYP·M Attimarad
Jul 10, 2014·Spectrochimica Acta. Part A, Molecular and Biomolecular Spectroscopy·Hala E ZaazaaMohamed Abdelkawy
Oct 14, 2008·Drug Development and Industrial Pharmacy·Alaa el-GindyShehab Sallam

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