Enantioseparation and Determination of Sibutramine in Pharmaceutical Formulations by Capillary Electrophoresis

Bulletin of the Korean chemical society

Yu Seon Jang¹  Wonku Kang¹  Enqi Wu¹  Jong Seong Kang¹  Jung Kap Choi¹  Wonjae Lee¹  Chuvan Men¹  Hongmei Zhu¹  Jianbo Chen¹ 

关键词: Sibutramine;    Enantioseparation;    Chiral selector;    Methyl-¥â-cyclodextrin;    Capillary electrophoresis;   

DOI  :  

学科分类：化学（综合）

来源: Korean Chemical Society

【 摘 要 】

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-�?-cyclodextrin (pH 4.3) or 5 mM carboxymethyl- �?-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.

【 授权许可】

Unknown