Enantiomeric purity control of levocetirizine in pharmaceuticals using anionic cyclodextrin mediated capillary electrophoresis separation and fiber-based diode array detection.
The present work illustrates potential of anionic cyclodextrin (CD) mediated capillary electrophoresis (CE) separation technique coupled with on-capillary diode array detector (DAD) for highly reliable enantioselective determination of dextrocetirizine (DCET) besides its major active compound (levocetirizine, LCET) in pharmaceuticals (commercial tablets). DAD detection was utilized for the characterization of composition of each separated zone via match of corresponding tested (analyte in dosage form) and reference (standard analyte in water) UV-VIS spectrum (scanned in interval 200-800 nm) being expressed mathematically through Pearson's correlation coefficient (PCC). It was demonstrated, comparing the reference and real spectra of CET enantiomers, that the applied separation method was selective enough to produce pure (spectrally homogeneous) zones of interest without any interfering comigrating compound (PCCs values were equal or higher than 0.99). Successful validation of the proposed CE-DAD method suggests its routine use for the control of enantiomeric purity of pharmaceuticals.
Mikus
P
P
Department of Pharmaceutical Analysis and Nuclear Pharmacy, Faculty of Pharmacy, Comenius University, Odbojárov 10, 832 32 Bratislava, Slovak Republic. mikus@fpharm.uniba.sk
Maráková
K
K
Valásková
I
I
Havránek
E
E
D000838:Anions / Q000737:chemistry; D017332:Cetirizine / Q000737:chemistry*; D003505:Cyclodextrins / Q000737:chemistry*; D019075:Electrophoresis, Capillary; D039563:Histamine H1 Antagonists, Non-Sedating / Q000737:chemistry*; D011786:Quality Control; D012015:Reference Standards; D015203:Reproducibility of Results; D013237:Stereoisomerism; D013607:Tablets / Q000032:analysis
D000838:Anions; D003505:Cyclodextrins; D039563:Histamine H1 Antagonists, Non-Sedating; D013607:Tablets; C472067:levocetirizine; D017332:Cetirizine