engleski

Maximising benefits and minimizing harms from drugs imatinib determination in human serum by high-performance liquid chromatography

Introduction: Imatinib is a 2-phenylaminopyrimidine derivative that functions as a specific inhibitor of a number of tyrosine kinase enzymes. It is used in chronic myelogenous leukemia (CML), gastrointestinal stromal tumors (GISTs) and a number of other malignancies. Materials and Methods: The aim of this study was to develop and validate sensitive and specific high-perfomance liquid chromatography (HPLC) method for the determination of imatinib in serum/plasma. Imatinib was extracted from serum with methanol. Clozapine was used as an internal standard. The sample was fractionated on a column MN EC Nucleosil 100-5-C-18 EC 250 x 4.6 mm with a mobile system consisting of ammonium acetate buffer, methanol and acetonitrile (40:40:20). The flow rate was 0.75 ml min-1. Quantitation was performed by measurement of UV detector at the wavelength of 265 nm. Results: Calibration curve was linear in the range of 40 - 5000 ng/ml, limit of detection (LOD) was 13.1 ng/ml and limit of quantitation (LOQ) was 38.6 ng/m. Recovery ranged from 94.1% to 105.7%. Repeatability expressed as a coefficient of variation was 4.90% and 1.95% for 75 and 1500 ng/ml, respectively, and the coefficient of variation for intermediate precision was <10.0%. Stability of the analyte during several freeze/thaw cycles and long-term stability (during 21 days) was good. Conclusion: The method proved to be simple, useful, enough sensitive and specific for routine monitoring of imatinib concentrations in patients with chronic myelogenous leukemia.

imatinib; human serum; HPLC

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