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

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F61989592%3A15310%2F16%3A33161362" target="_blank" >RIV/61989592:15310/16:33161362 - isvavai.cz</a>

Výsledek na webu

<a href="http://dx.doi.org/10.1515/chempap-2016-0047" target="_blank" >http://dx.doi.org/10.1515/chempap-2016-0047</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1515/chempap-2016-0047" target="_blank" >10.1515/chempap-2016-0047</a>

Jazyk výsledku

angličtina

Název v původním jazyce

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

Popis výsledku v původním jazyce

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-gamma-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.

Název v anglickém jazyce

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

Popis výsledku anglicky

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-gamma-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.

Druh

J_x - Nezařazeno - Článek v odborném periodiku (Jimp, Jsc a Jost)

CEP obor

CB - Analytická chemie, separace

OECD FORD obor

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Projekt

Výsledek vznikl pri realizaci vícero projektů. Více informací v záložce Projekty.

Návaznosti

P - Projekt vyzkumu a vyvoje financovany z verejnych zdroju (s odkazem do CEP)

Rok uplatnění

2016

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Chemical Papers

ISSN

0366-6352

e-ISSN

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Svazek periodika

70

Číslo periodika v rámci svazku

8

Stát vydavatele periodika

SK - Slovenská republika

Počet stran výsledku

7

Strana od-do

1024-1030

Kód UT WoS článku

000378421200002

EID výsledku v databázi Scopus

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