DEVELOPMENT OF A HIGHLY SENSITIVE HIGH-PERFORMANCE LIQUID-CHROMATOGRAPHIC METHOD FOR MEASURING AN ANTICANCER DRUG, UCN-01, IN HUMAN PLASMA OR URINE

We have established a highly sensitive high-performance liquid chromat ographic method for the determination of an anticancer drug, UCN-01 , in human plasma or urine. Using a fluorescence detector set at an exci tation wavelength of 310 nm and emission monitored at 410 nm, there wa s a good linearity for UCN-01 in human plasma (r=0.999) or urine (r=0. 999) at concentrations ranging from 0.2 to 100 ng/ml or 1 to 400 ng/ml , respectively. For intra-day assay, in plasma samples, the precision and accuracy were 1.8% to 5.6% and -10.0% to 5.2%, respectively. For i nter-day assay, the precision and accuracy were 2.0% to 18.2% and 2.4% to 10.0%, respectively. In urine samples, the intra-and inter-day pre cision and accuracy were within 3.9% and +/-2.7%, respectively. The lo wer limit of quantification (LLOQ) was set at 0.2 ng/ml in plasma and 1 ng/ml in urine. UCN-01 in plasma samples was stable up to two weeks at -80 degrees C and also up to four weeks in urine samples. This meth od could be very useful for studying the human pharmacokinetics of UCN -01. (C) 1998 Elsevier Science B.V.