Optimisation and validation of a new CE method for the determination of lansoprazole enantiomers in pharmaceuticals.
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.
Nevado
Juon José Berzas
JJ
Department of Analytical Chemistry and Food technology, Faculty of Chemistry, University of Castilla-La Mancha, Ciudad Real, Spain. juanjose.berzas@uclm.es
Peñalvo
Gregorio Castañeda
GC
Sánchez
Juan Carlos Jiménez
JC
Mochón
Manuel Callejón
MC
Dorado
Rosa María Rodríguez
RM
Navarro
Mercedes Villar
MV
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
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D004364:Pharmaceutical Preparations; D013440:Sulfides; D047392:beta-Cyclodextrins; D064747:Lansoprazole; C033479:sodium sulfide