Development and Validation of a Sensitive LC-MS/MS Method for Quantifying Sirolimus in Human Whole Blood

摘要

A highly sensitive and selective LC-MS/MS sirolimus assay with 50 pg/mL LLOQ in human whole blood was validated on an API 4000 mass spectrometer to support lower efficacious dose clinical studies. Sirolimus is stable in human whole blood after 22.5 hours at room temperature and 6 freeze/thaw cycles, and at least 101 days of storage at both -20 deg C and -70 deg C. 10-fold dilution linearity is demonstrated by diluting whole blood samples with blank matrix. The reinjection reproducibility is good for the processed samples after storage at room temperature for 158 hours. This method has been successfully used to support three bioavailability and pharmacokinetics (PK) studies.