Abstract

A high-performance liquid chromatographic (HPLC) method was developed for the simultaneous determination of seratrodast, a new antiasthmatic drug, and its metabolites (M-I to M-III) in human serum and urine. The method for serum and urine with and without enzymatic hydrolysis using β-glucuronidase involved liquid–liquid extraction and chemical oxidation with iron(III) chloride. The compounds in the extract were analyzed using HPLC with UV detection at 266 nm. The detection limits of seratrodast, M-I, M-II and M-III in serum and urine were 5–10 and 5–20 ng/ml, respectively, and those of deconjugated compounds in urine were 10–50 ng/ml. The method was applicable for human serum and urine from clinical trials.

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