CZE Separation of New Drugs for Treatment of Leukemia
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Imatinib, bosutinib, dasatinib, pazopanib, erlotinib, canertinib and vatalanib are new developed anticancer drugs, especially for treatment of leukemia. In this article, a fast and high throughput capillary zone electrophoresis method has been developed and validated for analysis of these new drugs in pharmaceutical formulas. The method can be easily utilized for determination of all the drugs in one run what is advantageous for the quality control in pharmaceutical industry because there is no need for changing and optimization of separation conditions when changing the analyte. The separation was performed using an uncoated fused silica capillary with 100 mmol L−1 sodium phosphate buffer pH 2.75, voltage of 25 kV, hydrodynamic injection time of 5 s by 50 mbar, and detection at 214 nm. Under these conditions, the analysis took about 8 min. The validation of all the drugs resulted in recoveries in the range of 84–100 %. The method showed to be precise for all the drugs with RSDs of migration times lower than 0.9 % (interday precision). A very good linearity in the validated range (5–100 μg mL−1) and the limits of detection (LODs) in the range of 0.5–2.0 (μg mL−1) were achieved. Finally, we proved that the method is robust by the Youden’s test. Therefore, our method can be successfully applied for analysis of the real pharmaceutical samples.
KeywordsCapillary zone electrophoresis Leukemia Drugs Validation Pharmaceutical analysis
The financial support of the research by the Operational Program Research and Development for Innovations—European Regional Development Fund (project CZ.1.05/2.1.00/03.0058), the Operational Program Education for Competitiveness—European Social Fund (project CZ.1.07/2.3.00/20.0018), the Grant Agency of the Czech Republic (project P206/12/1150), and the Student project UP Olomouc IGA_PrF_2014_031 is gratefully acknowledged.
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