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

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 24h 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 AUC24(0) and Cmax for each of the two formulations examined. However, the mean AUC24(0) RIA/GC-MS ratios for formulations A and B were 3.1 and 3.4, respectively, while the mean Cmax RIA/GC-MS ratios were 1.7 and 2.1, respectively. These differences in AUC and Cmax 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.

Stability Indicating HPLC Method for Simultaneous Quantification of Trihexyphenidyl Hydrochloride, Trifluoperazine Hydrochloride and Chlorpromazine Hydrochloride from Tablet Formulation

“…The literature survey revels that there are verity of analytical method for the quantification of THP, TFP and CLP from mono formulation or from biological matrix. The available methods for quantification of THP from formulation or from biological samples are based on LC-MS 5 , GC 6 , Capillary zone electrophoresis [7][8] , HPLC with UV detector 9 , UV-spectroscopy 10 and TLC and for quantification 11 of TFP from formulation or from biological samples are based on LC-MS 12 , HPLC with UV detector [13][14][15][16] , UV-spectroscopy 15,[17][18][19] , TLC 15,20 , GC-MS 21 , voltametric 22 and Fluorimetric 23 , however for quantification of CLP from formulation or from biological samples are based on LC-MS [24][25] , HPLC with UV detector [26][27][28][29][30][31][32] , UV-spectroscopy [33][34][35] , GC-MS 36,37 , TLC 38 , Potentiometer [39][40][41] , NMR 42 , Radioimmunoassay 43 , Fluorimetry 44 , Chemiluminescence 45 , Electron spin resonance spectroscopy 46 .…”