HPLC-UV ASSAY OF IMATINIB IN HUMAN PLASMA OPTIMIZED FOR BIOEQUIVALENCE STUDIES.

lmatimb is an anticancer drug approved for the treatment of a number of cancers, mostly used in chronic myeloid leukemia. Numerous bioanalytical methods using high performance liquid chromatography coupled to ultraviolet detection point at the importance and necessity of the therapeutic drug monitoring of imatinib. Unfortunately, these methods are not optimized for single dose pharmacokinetic studies such as bioe- quivalence. In this study, attention was turned mostly to the analysis time, linearity range and interferences by endogenous components of the matrix and exogenous substances - especially metabolites. The method enables the quantification of imatinib in the presence of the main metabolite (N-desmethyl imatinib). Its potential back- conversion was examined during storage for 4 h at ambient temperature as well as for 239 days at -20⁰C. The sample preparation based on the liquid-liquid extraction was combined with a short analysis time of 7 min. Therefore, the method was suitable for analyzing large numbers of samples in a short time. The linearity range of 40-4000 ng/mL was optimized for human pharmacokinetic studies after a single 400 mg oral dose of ima- tinib. Successful application in a bioequivalence study confirmed the reliability of the method.