Method Development and Validation of a Turbo Ion Spray LC/MS/MS Method for Capecitabine and Its Four Major Metabolites in Human Plasma

摘要

An LC/MS/MS method for the determination of capecitabine and four major metabolites was validated. Assay demonstrates excellent precision and accuracy. Plasma stability in an ice-bath was established for up to 4 hours for 5'-DFCR and up to 24 hours for capecitabine, 5'-DFUR, 5-FU and FBAL and after five freeze/thaw cycles (frozen at -70 deg C) for all compounds. Analytes were stable in whole blood after 1 hour in an ice bath and at room temperature. Plasma extracts were stable at room temperature for 6 days. Stability of processed samples was established for 70 hours for 5-FU and for 98 hours for capecitabine, 5'-DFCR, 5'-DFUR, and FBAL. Storage stability has been established for 600 days at -70 deg C.