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Chemical Papers


IMPACT FACTOR 2016: 1.258

SCImago Journal Rank (SJR) 2016: 0.348
Source Normalized Impact per Paper (SNIP) 2016: 0.533

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1336-9075
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Volume 70, Issue 8 (Aug 2016)

Issues

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

Pavlína Ginterová
  • Regional Centre of Advanced Technologies and Materials, Department of Analytical Chemistry, Faculty of Science, Palacký University in Olomouc, 17. listopadu 12, Olomouc, CZ-771 46, Czech Republic
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Joanna Znaleziona
  • Corresponding author
  • Regional Centre of Advanced Technologies and Materials, Department of Analytical Chemistry, Faculty of Science, Palacký University in Olomouc, 17. listopadu 12, Olomouc, CZ-771 46, Czech Republic
  • Email
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Radim Knob
  • Regional Centre of Advanced Technologies and Materials, Department of Analytical Chemistry, Faculty of Science, Palacký University in Olomouc, 17. listopadu 12, Olomouc, CZ-771 46, Czech Republic
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Michal Douša / Jan Petr
  • Regional Centre of Advanced Technologies and Materials, Department of Analytical Chemistry, Faculty of Science, Palacký University in Olomouc, 17. listopadu 12, Olomouc, CZ-771 46, Czech Republic
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Juraj Ševčík
  • Regional Centre of Advanced Technologies and Materials, Department of Analytical Chemistry, Faculty of Science, Palacký University in Olomouc, 17. listopadu 12, Olomouc, CZ-771 46, Czech Republic
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
Published Online: 2016-04-22 | DOI: https://doi.org/10.1515/chempap-2016-0047

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-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.

Keywords: capillary electrophoresis; chiral separation; cinacalcet; Mimpara

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About the article

Received: 2015-09-23

Revised: 2015-12-16

Accepted: 2016-01-04

Published Online: 2016-04-22

Published in Print: 2016-08-01


Citation Information: Chemical Papers, ISSN (Online) 1336-9075, ISSN (Print) 0366-6352, DOI: https://doi.org/10.1515/chempap-2016-0047.

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