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A bioequivalency study of two trifluoperazine tablet formulations using ria and GC–MS

1984; Wiley; Volume: 5; Issue: 1 Linguagem: Inglês

10.1002/bdd.2510050105

1099-081X

K.K. Midha, E. M. Hawes, E. D. Korchinski, John W. Hubbard, G. McKay, J.K. Cooper, Robyn Roscoe,

Antibiotics Pharmacokinetics and Efficacy

Abstract Two sensitive analytical procedures, a radioimmunoassay (RIA) and a mass fragmentographic (GC–MS) method, were used to quantitate plasma trifluoperazine concentrations over 24 h in five healthy male volunteers following single 5 mg doses of two trifluoperazine tablet formulations (A and B) in a two‐way cross‐over design. Bioavailability in terms of area under the plasma concentration versus time curve to 24 h or extrapolated to infinity, maximum plasma concentration and time to maximum plasma concentration using either RIA or GC–MS was not statistically significantly different from one formulation to the other. Also, there were no statistically significant differences between GC–MS and RIA values for AUC 0 24 and C max for each of the two formulations examined. However, the mean AUC 0 24 RIA/GC–MS ratios for formulations A and B were 3·1 and 3·4, respectively, while the mean C max RIA/GC–MS ratios were 1·7 and 2·1, respectively. These differences in AUC and C max are probably mainly due to the relative non‐specificity of the RIA antiserum. Thus, where GC–MS is preferred for pharmacokinetic studies, both analytical procedures can be used for comparative single‐dose bioequivalence studies of trifluoperazine. However, both the methods should be tested in patients in order to establish the suitability of one procedure over the other for the study of plasma level versus clinical response correlations.