Optimization and validation of a new CE method for the determination of pantoprazole enantiomers

A new CE method using sulfobutylether‐beta‐cyclodextrin ( SBE ‐beta‐ CD ) as chiral additive was developed and validated for the determination of pantoprazole enantiomers. The primary factors affecting its separation efficiency, which include chiral selector, buffer p H , organic additive, and applied voltage, were optimized. The best results were obtained using a buffer consisting of 50 mM borax‐150 mM phosphate adjusted to pH 6.5, 20 mg/mL SBE ‐beta‐ CD , and a 10 kV applied voltage. The optimized method was validated for linearity, precision, accuracy, and proved to be robust. The LOD and LOQ for R ‐(+)‐pantoprazole were 0.9 and 2.5 μg/mL, respectively. The method is capable of determining a minimum limit of 0.1% (w/w) of R ‐enantiomer in S ‐(–)‐pantoprazole bulk samples.