title: Chiral chromatography studies of chemical behavior of cinacalcet on polysaccharide chiral reversed-phase HPLC stationary phases.
abstract: 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.
authors: Zentiva, a.s. Praha, U Kabelovny 130, 102 37 Praha 10, Czech Republic. hplc@hplc.cz
authors: Michal
authors: M
authors: Dousa
authors: Jirí
authors: J
authors: Brichác
mesh_terms: D000438:Alcohols; D000465:Algorithms; D002021:Buffers; D002851:Chromatography, High Pressure Liquid; D000069449:Cinacalcet; D006863:Hydrogen-Ion Concentration; D007202:Indicators and Reagents; D057230:Limit of Detection; D009281:Naphthalenes / Q000737:chemistry*; D011134:Polysaccharides / Q000737:chemistry*; D012015:Reference Standards; D015203:Reproducibility of Results; D012997:Solvents; D013237:Stereoisomerism; D013696:Temperature
chemical_list: D000438:Alcohols; D002021:Buffers; D007202:Indicators and Reagents; D009281:Naphthalenes; D011134:Polysaccharides; D012997:Solvents; D000069449:Cinacalcet