HIGH-PERFORMANCE LIQUID-CHROMATOGRAPHIC DETERMINATION OF PIOGLITAZONEAND ITS METABOLITES IN HUMAN SERUM AND URINE

A high-performance liquid chromatographic (HPLC) method for the simult aneous determination of pioglitazone and its metabolites (M-I to M-V) in human serum and urine was developed. The method for serum involved the solid-phase and liquid-liquid extraction. Urine with and without e nzymatic hydrolysis using beta-glucuronidase was treated with liquid-l iquid extraction. The compounds in the extract were analyzed using HPL C with UV detection at 269 nm. The detection limits of pioglitazone, M -I, M-II, M-III, M-IV and M-V in serum were 0.01-0.05 mu g/ml, those i n urine were 0.1-0.5 mu g/ml, and those in urine after enzymatic hydro lysis were 0.3-0.5 mu g/ml, respectively. The method was applied to th e clinical trials of pioglitazone.