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Chiral separation of cetirizine by capillary electrophoresis
Author(s) -
Van Eeckhaut Ann,
Michotte Yvette
Publication year - 2006
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.200500844
Subject(s) - cetirizine , chromatography , levocetirizine , capillary electrophoresis , chemistry , enantiomer , detection limit , triethanolamine , selectivity , phosphate buffered saline , analytical chemistry (journal) , stereochemistry , pharmacology , biochemistry , medicine , organic chemistry , catalysis
Chiral separation of cetirizine, a second‐generation H 1 ‐antagonist, was studied by CD‐mediated CE. Several parameters, including pH, CD type, buffer concentration, type of co‐ion, applied voltage and temperature, were investigated. The best conditions for chiral separation were obtained using a 75 mM triethanolamine‐phosphate buffer (pH 2.5) containing 0.4 mg/mL heptakis(2,3‐diacetyl‐6‐sulfato)‐β‐CD and 10% ACN. Online UV detection was performed at 214 nm, a voltage of 20 kV was applied and the capillary was temperature controlled at 25°C by liquid cooling. Hydrodynamic injection was performed for 1 s. The method was validated for the quantification of levocetirizine in tablets and for enantiomeric purity testing of the drug substance. Selectivity, linearity, LOD and LOQ, precision and accuracy were evaluated for both methods. The amount of levocetirizine dihydrochloride in the commercially available tablets was quantified and was found to be within the specification limits of the claimed amount (5 mg). The amount of distomer in levocetirizine drug substance was found to be 0.87 ± 0.09% w/w, which is in agreement with the certificate of analysis supplied by the company.