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Optimization and validation of a new CE method for the determination of pantoprazole enantiomers
Author(s) -
Guan Jin,
Yan Feng,
Shi Shuang,
Wang Silin
Publication year - 2012
Publication title -
electrophoresis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.666
H-Index - 158
eISSN - 1522-2683
pISSN - 0173-0835
DOI - 10.1002/elps.201100650
Subject(s) - pantoprazole , enantiomer , chromatography , phosphate buffered saline , detection limit , chemistry , cyclodextrin , borax , analytical chemistry (journal) , stereochemistry , medicine , omeprazole , raw material , organic chemistry
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.