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

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. Th e method for serum and urine with and without enzymatic hydrolysis usi ng beta-glucuronidase involved liquid-liquid extraction and chemical o xidation with iron(III) chloride. The compounds in the extract were an alyzed 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 5-2 0 ng/ml, respectively, and those of deconjugated compounds in urine we re 10-50 ng/ml. The method was applicable for human serum and urine fr om clinical trials. (C) 1997 Elsevier Science B.V.