Enantiomeric purity control of <Emphasis Type="Italic">R</Emphasis>-cinacalcet in pharmaceutical product by capillary electrophoresis

The capillary zone electrophoresis method was developed for the chiral separation of R,S-cinacalcet. Cyclodextrins with different substituents were tested in both acidic and alkaline background electrolytes. The non-ionic cyclodextrin, 2-hydroxypropyl-γ-cyclodextrin, was selected as the best chiral selector. The separation was performed using a positive voltage in a phosphate buffer at pH 2.5. The analytes studied were separated within 12 min. The proposed method was applied to the analysis of tablets containing R-cinalcalcet as the active substance. The enantiopurity of R-cinacalcet in the tablets studied was confirmed. Subsequently, the analysis of tablets spiked with S-cinacalcet (chiral impurity) was also performed. The method here presented makes possible the determination of 0.1 % of S-cinacalcet in tablets. The analytical characteristics of the method, such as linearity, recovery and RSD values of the peak area and the migration time, were evaluated. The inter-day RSD values of the peak area and the migration time were lower than 3.71 % and 1.3 %, respectively.     

CZE Separation of New Drugs for Treatment of Leukemia

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.