Document Detail

Determination of related impurities of bile acids in bulk drugs by cyclodextrin-modified micellar electrokinetic chromatography.
MedLine Citation:
PMID:  10797879     Owner:  NLM     Status:  MEDLINE    
A cyclodextrin-modified micellar electrokinetic chromatography (CD-MEKC) method has been developed and validated for purity determination of two bile acids, ursodeoxycholic acid (UDCA) and deoxycholic acid (DCA). Quantitation of related impurities such as lithocholic acid (LCA), chenodeoxycholic acid (CDCA), cholic acid (CA), and DCA in UDCA and CA in DCA was performed. A running buffer containing 20 mM borate-phosphate, 50 mM sodium dodecyl sulfate (SDS), 2.0 mM beta-cyclodextrin, and acetonitrile was used. Modifiers were added to improve resolution and selectivity. The applied voltage was 25 kV and detection was performed at 185 nm. Validation parameters such as selectivity, linearity, repeatability, intermediate precision, limit of detection, limit of quantitation, and robustness were evaluated. The method was simple and proved to be useful for the purity testing of bile acids in bulk drugs. Good results were obtained for related impurities at concentration levels from 0.05 to 1.5% with respect to the main component, according to international requirements.
S E Lucangioli; V G Rodríguez; G C Fernández Otero; C N Carducci
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of capillary electrophoresis     Volume:  5     ISSN:  1079-5383     ISO Abbreviation:  J Capillary Electrophor     Publication Date:    1998 May-Aug
Date Detail:
Created Date:  2000-06-08     Completed Date:  2000-06-08     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  9507610     Medline TA:  J Capillary Electrophor     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  139-42     Citation Subset:  IM    
Department of Analytical Chemistry and Physicochemistry, Faculty of Pharmacy and Biochemistry, University of Buenos Aires, Argentina.
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MeSH Terms
Chromatography, Micellar Electrokinetic Capillary / methods*,  standards
Deoxycholic Acid / analysis*
Molecular Structure
Ursodeoxycholic Acid / analysis*
Reg. No./Substance:
0/Cyclodextrins; 0/beta-Cyclodextrins; 128-13-2/Ursodeoxycholic Acid; 7585-39-9/betadex; 83-44-3/Deoxycholic Acid

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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