Chiral chromatography studies of chemical behavior of cinacalcet on polysaccharide chiral reversed-phase HPLC stationary phases
Language English Country Great Britain, England Media print
Document type Journal Article
- MeSH
- Algorithms MeSH
- Alcohols MeSH
- Cinacalcet MeSH
- Indicators and Reagents MeSH
- Hydrogen-Ion Concentration MeSH
- Limit of Detection MeSH
- Naphthalenes chemistry MeSH
- Polysaccharides chemistry MeSH
- Buffers MeSH
- Reference Standards MeSH
- Reproducibility of Results MeSH
- Solvents MeSH
- Stereoisomerism MeSH
- Temperature MeSH
- Chromatography, High Pressure Liquid MeSH
- Publication type
- Journal Article MeSH
- Names of Substances
- Alcohols MeSH
- Cinacalcet MeSH
- Indicators and Reagents MeSH
- Naphthalenes MeSH
- Polysaccharides MeSH
- Buffers MeSH
- Solvents MeSH
A rapid HPLC method for the analytical resolution of cinacalcet enantiomers was developed. Four chiral columns (two amylose and two cellulose type) were evaluated in RP systems. Excellent enantioseparation with a resolution of more than 6 was achieved on Chiralpak AY (amylose 5-chloro-2-methylphenylcarbamate chiral stationary phase) using 10 mM triethylamine (pH 8.0)-acetonitrile (40 + 60, v/v) mobile phase. Validation of the HPLC method, including linearity, LOD, LOQ, precision, accuracy, and selectivity, was performed according to the International Conference on Harmonization guidelines. The method was successfully applied for the determination of (S)-cinacalcet in enantiopure active pharmaceutical ingredient (R)-cinacalcet.
References provided by Crossref.org
