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


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2016-08

AUTHORS

Pavlína Ginterová, Joanna Znaleziona, Radim Knob, Michal Douša, Jan Petr, Juraj Ševčík

ABSTRACT

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. More... »

PAGES

1024-1030

References to SciGraph publications

Identifiers

URI

http://scigraph.springernature.com/pub.10.1515/chempap-2016-0047

DOI

http://dx.doi.org/10.1515/chempap-2016-0047

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https://app.dimensions.ai/details/publication/pub.1011541928


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