Chiral separation of lansoprazole and rabeprazole by capillary electrophoresis using dual cyclodextrin systems
Autor: | Zoltán-István Szabó, Béla Noszál, Gergő Tóth, Lajos Attila Papp, Hajnal Kelemen, Pavel Dubský, Árpád Gyéresi, Gabriel Hancu |
---|---|
Rok vydání: | 2019 |
Předmět: |
Materials science
Central composite design Clinical Biochemistry Rabeprazole Lansoprazole 02 engineering and technology 01 natural sciences Biochemistry Analytical Chemistry Capillary electrophoresis Limit of Detection medicine Dexlansoprazole chemistry.chemical_classification Cyclodextrins Chromatography Cyclodextrin 010401 analytical chemistry Electrophoresis Capillary Reproducibility of Results Fractional factorial design Stereoisomerism 021001 nanoscience & nanotechnology 0104 chemical sciences chemistry Linear Models Enantiomer 0210 nano-technology medicine.drug |
Zdroj: | ELECTROPHORESIS. 40:2799-2805 |
ISSN: | 1522-2683 0173-0835 |
DOI: | 10.1002/elps.201900107 |
Popis: | Novel capillary electrophoresis methods using CDs as chiral selectors were developed and validated for the chiral separation of lansoprazole and rabeprazole, two proton pump inhibitors. Fourteen different neutral and anionic CDs were screened at pH 4 and 7 in the preliminary analysis. Sulfobutyl-ether-β-CD with a degree of substitution of 6.5 and 10 at neutral pH proved to be the most suitable chiral selector for both compounds. Various dual CD systems were also compared, and the possible mechanisms of enantiomer separation were investigated. A dual selector system containing sulfobutyl-ether-β-CD degree of substitution 6.5 and native γ-CD proved to be the most adequate system for the separations. Method optimization was carried out using an experimental design approach, performing an initial fractional factorial screening design, followed by a central composite design to establish the optimal analytical conditions. The optimized methods (25 mM phosphate buffer, pH 7, 10 mM sulfobutyl-ether-β-CD/20 mM γ-CD, +20 kV voltage; 17°C temperature; 50 mbar/3 s injection, detection at 210 nm for lansoprazole; 25 mM phosphate buffer, pH 7, 15 mM sulfobutyl-ether-β-CD/30 mM γ-CD, +20 kV voltage; 18°C temperature; 50 mbar/3 s injection, detection at 210 nm for rabeprazole) provided baseline separation for lansoprazole (Rs = 2.91) and rabeprazole (Rs = 2.53) enantiomers with favorable migration order (in both cases the S-enantiomers migrates first). The optimized methods were validated according to current guidelines and proved to be reliable, linear, precise, and accurate for the determination of 0.15% distomer as chiral impurity in dexlansoprazole and dexrabeprazole samples. |
Databáze: | OpenAIRE |
Externí odkaz: |