title: Optimisation and validation of a new CE method for the determination of lansoprazole enantiomers in pharmaceuticals.
abstract: An analytical method based on CZE to determine lansoprazole enantiomers in pharmaceuticals was developed. The primary factors affecting its separation efficiency, which include chiral selector, pH, buffer concentration, capillary temperature and injection time, were optimised. The best results were obtained by using a background electrolyte consisting of 50 mM phosphate adjusted to pH 2.2, 12 mM beta-CD and 5 mM sodium sulphite, in combination with hydrodynamic injection and a 15 kV separation voltage. Detection limits were calculated from baseline noise and found to be 0.64 mg L(-1) for the R enantiomer and 0.72 mg L(-1) for the S enantiomer. The proposed method was used to analyse three different pharmaceutical preparations with recoveries of 91-102% of the label content.
authors.affiliation: Department of Analytical Chemistry and Food technology, Faculty of Chemistry, University of Castilla-La Mancha, Ciudad Real, Spain. juanjose.berzas@uclm.es
authors.forename: Juon José Berzas
authors.initials: JJ
authors.lastname: Nevado
authors.forename: Gregorio Castañeda
authors.initials: GC
authors.lastname: Peñalvo
authors.forename: Juan Carlos Jiménez
authors.initials: JC
authors.lastname: Sánchez
authors.forename: Manuel Callejón
authors.initials: MC
authors.lastname: Mochón
authors.forename: Rosa María Rodríguez
authors.initials: RM
authors.lastname: Dorado
authors.forename: Mercedes Villar
authors.initials: MV
authors.lastname: Navarro
mesh_terms: D053799:2-Pyridinylmethylsulfinylbenzimidazoles / Q000032:analysis / Q000737:chemistry; D004355:Drug Stability; D019075:Electrophoresis, Capillary / Q000379:methods*; D006863:Hydrogen-Ion Concentration; D064747:Lansoprazole; D016014:Linear Models; D004364:Pharmaceutical Preparations / Q000737:chemistry*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013237:Stereoisomerism; D013440:Sulfides / Q000737:chemistry; D013696:Temperature; D047392:beta-Cyclodextrins / Q000737:chemistry
chemical_list: D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D004364:Pharmaceutical Preparations; D013440:Sulfides; D047392:beta-Cyclodextrins; D064747:Lansoprazole; C033479:sodium sulfide