title: The bioequivalence study of baclofen and lioresal tablets using capillary electrophoresis.
abstract: A simple and robust analytical method for rapid separation and sensitive quantification of baclofen in human plasma by capillary electrophoresis technique was developed. Electrophoretic separation was optimized and successfully performed using simple sodium tetraborate aqueous solution. Observed detection limit in biological material was 10 ng. Using UV detection at 200 nm excellent linearity (r = 0.999) was observed over the concentration range from 0.025 to 1.0 microg mL(-1). The described method has been validated and applied to the quantitative determination of baclofen in human plasma. The bioavailability of Baclofen (Polpharma) and Lioresal (Novartis) in 18 healthy volunteers was investigated. The results indicate bioequivalence of the reference and Baclofen preparations.
authors.affiliation: Medical University of Gdańsk, Faculty of Pharmacy, Hallera 107, PL-80-416 Gdańsk, Poland.
authors.forename: Piotr
authors.initials: P
authors.lastname: Kowalski
authors.forename: Aleksandra
authors.initials: A
authors.lastname: Chmielewska
authors.forename: Lucyna
authors.initials: L
authors.lastname: Konieczna
authors.forename: Ilona
authors.initials: I
authors.lastname: Oledzka
authors.forename: Paweł K
authors.initials: PK
authors.lastname: Zarzycki
authors.forename: Henryk
authors.initials: H
authors.lastname: Lamparczyk
mesh_terms: D000328:Adult; D001418:Baclofen / Q000032:analysis* / Q000493:pharmacokinetics; D019075:Electrophoresis, Capillary / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D012016:Reference Values; D012680:Sensitivity and Specificity; D013607:Tablets / Q000737:chemistry*; D013810:Therapeutic Equivalency
chemical_list: D013607:Tablets; D001418:Baclofen