Chiral separation of dioxopromethazine in eye drops by CZE with charged cyclodextrin

• Published in: Journal of pharmaceutical and biomedical analysis 2003-09, Vol.33 (2), p.157-164
• Main Authors: MIKUS, Peter, VALASKOVA, Iva, HAVRANEK, Emil
• Format: Article
• Language: English
• Subjects: Analysis; Antihistamines; Biological and medical sciences; Capillary zone electrophoresis; Carboxyethyl-β-cyclodextrin; Charged cyclodextrin; Cyclodextrins - chemistry; Dioxopromethazine; Drugs; Electrolytes; Electrophoresis, Capillary; Enantioseparation; General pharmacology; Hydrogen-Ion Concentration; Indicators and Reagents; Medical sciences; Ophthalmic Solutions - chemistry; Pharmaceutical preparation; Pharmacology. Drug treatments; Promethazine - analogs & derivatives; Promethazine - isolation & purification; Reproducibility of Results; Spectrophotometry, Ultraviolet; Stereoisomerism
• ISSN: 0731-7085; 1873-264X
• DOI: 10.1016/S0731-7085(03)00254-1

Capillary zone electrophoresis (CZE) with carboxyethyl-β-cyclodextrin (CE-β-CD) dissolved in the operating buffer was used for the separation and determination of enantiomers of phenothiazine antihistaminic, dioxopromethazine, in commercial pharmaceutical preparation, eye drops. This chiral selector, negatively charged under given separating conditions (20 mmol/l ε-aminocaproic acid, acetic acid, pH 4.5), was effective in enantioresolution of the antihistamine even at its low concentrations (3–6 mg/ml) in the buffer solution. CZE identification and quantitation of the relevant constituents present in the preparation (dioxopromethazine enantiomers, phenylephrine) were based on the response of photometric absorbency detector, operating at a 275 nm detection wavelength. Changes in pH, type and concentration of chiral selector were studied in relation to chiral resolution. Acceptable validation criteria for sensitivity, precision, linearity and repeatability are included.