Enantiomeric purity control of R-cinacalcet in pharmaceutical product by capillary electrophoresis

Abstract

The capillary zone electrophoresis method was developed for the chiral separation of R,Scinacalcet. Cyclodextrins with different substituents were tested in both acidic and alkaline background electrolytes. The non-ionic cyclodextrin, 2-hydroxypropyl-ã-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.