Clinical development of imatinib: an anticancer drug.

BACKGROUND:A novel and accurate high-throughput tandem mass spectroscopic method has been developed and validated for determination of imatinib, a protein-tyrosine kinase inhibitor against chronic myeloid leukemia. MATERIALS & METHODS:Chromatographic separation was carried on XTerra® RP18 column (150 mm × 4.6 mm, 5 µm particle size) manufactured by Waters Corporation, MA, USA. The detection was performed on a triple quadruple tandem mass spectrometer by multiple reactions monitoring mode via electrospray ionization source. RESULTS:The selective and sensitive method was linear in the concentration range of 9.57-4513.29 ng/ml and reported no matrix effect. CONCLUSION:The mean Cmax was found to be 10-15% lower in European subjects as compared with Indian subjects.