INVESTIGADORES
LUCANGIOLI Silvia Edith
artículos
Título:
DETERMINATION OF RELATED IMPURITIES OF BILE ACIDS IN BULK DRUGS BY CYCLODEXTRIN-MODIFIED MICELLAR ELECTROKINETIC CHROMATOGRAPHY
Autor/es:
LUCANGIOLI S.,; RODRIGUEZ V.,; FERNANDEZ OTERO G.,; CARDUCCI C.
Revista:
JOURNAL OF CAPILLARY ELECTROPHORESIS
Editorial:
ISC TECHNICAL PUBLICATION
Referencias:
Lugar: SHELTON; Año: 1998 vol. 5 p. 139 - 142
ISSN:
1079-5383
Resumen:
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.