Abstract
A high-performance liquid chromatographic (HPLC) method for the simultaneous 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 enzymatic hydrolysis using β-glucuronidase was treated with liquid-liquid extraction. The compounds in the extract were analyzed using HPLC 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 μg/ml, those in urine were 0.1–0.5 μg/ml, and those in urine after enzymatic hydrolysis were 0.3–0.5 μg/ml, respectively. The method was applied to the clinical trials of pioglitazone.
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