THE DETECTION OF PHOTODEGRADATION PRODUCTS OF IRINOTECAN (CPT-11, CAMPTO(R), CAMPTOSAR(R)), IN CLINICAL-STUDIES, USING HIGH-PERFORMANCE LIQUID-CHROMATOGRAPHY ATMOSPHERIC-PRESSURE CHEMICAL-IONIZATION MASS-SPECTROMETRY

A method for the detection of the photodegradation products of irinote can (CPT-11, Campto(R), Camptosar(R)) was developed using high-perform ance liquid chromatography (HPLC) with fluorescence detection and HPLC /atmospheric pressure chemical ionisation/mass spectrometry (HPLC/APCI /MS). Remnants of infusion solution as well as samples of urine and pl asma collected at the end of the infusion of CPT-11 to cancer patients were screened for the five principal known photodegradation products (PDPs) of CPT-11. The concurrent use of standards of the PDPs with ion -extract HPLC/APCI/MS chromatograms enabled the identification of trac e quantities of two PDPs in most samples analysed. However, similar an alyses of fresh clinical drug solutions revealed that the PDPs were no t generated significantly by exposure to light during the infusion per iod, but were already present in the drug ampoules. Furthermore, this appears to be the source of traces of PDPs detectable in urine and pla sma of patients rather than metabolism, per se. (C) 1998 Elsevier Scie nce B.V. All rights reserved.