Enantioseparation and Determination of Sibutramine in Pharmaceutical Formulations by Capillary Electrophoresis

Title
Enantioseparation and Determination of Sibutramine in Pharmaceutical Formulations by Capillary Electrophoresis
Author(s)
강원구Hongmei Zhu[Hongmei Zhu]Enqi Wu[Enqi Wu]Jianbo Chen[Jianbo Chen]Chuvan Men[Chuvan Men]장유선[장유선]최정갑[최정갑]이원재[이원재]강종성[강종성]
Keywords
STABILITY-CONSTANTS; INCLUSION COMPLEXES; BINDING CONSTANTS; BETA-CYCLODEXTRIN; HYDROCHLORIDE; CHROMATOGRAPHY; ENANTIOMERS; SEPARATION
Issue Date
201006
Publisher
KOREAN CHEMICAL SOC
Citation
BULLETIN OF THE KOREAN CHEMICAL SOCIETY, v.31, no.6, pp.1496 - 1500
Abstract
Sibutramine enantiomers were separated successfully by capillary zone electrophoresis using substituted cyclodextrins as chiral selectors. The effects of cyclodextrin concentration, pH, voltage, buffer type, and electrolyte concentration on the migration time and resolution of enantiomers were examined. Separation of sibutramine enantiomers on an unmodified fused silica capillary (total length, 54 cm; effective length, 45 cm) was achieved using a mixed buffer of 20 mM phosphate/10 mM citrate containing either 5 mM methyl-beta-cyclodextrin (pH 4.3) or 5 mM carboxymethyl-beta-cyclodextrin (pH 6.5). Samples were injected with a pressure of 50 mbar for 5 s and were detected at a wavelength of 223 nm. The established method showed good precision and accuracy, with intra- and inter-day variations of less than 2.9 and 4.7%, respectively, and recoveries of 95.7 - 103.8%. The stability constants of (R)- and (S)-sibutramine demonstrated that the resolution of sibutramine enantiomers was attributable primarily to the difference in stability constants. When this optimized method was applied to the determination of sibutramine enantiomers in commercial drug formulations, it proved to be economical and convenient, affording sufficient accuracy, precision, and reproducibility as well as sensitivity and selectivity.
URI
http://hdl.handle.net/YU.REPOSITORY/22342http://dx.doi.org/10.5012/bkcs.2010.31.6.1496
ISSN
0253-2964
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약학대학 > 약학부 > Articles
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