The bioequivalence study of baclofen and lioresal tablets using capillary electrophoresis.
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.
Kowalski
Piotr
P
Medical University of Gdańsk, Faculty of Pharmacy, Hallera 107, PL-80-416 Gdańsk, Poland.
Chmielewska
Aleksandra
A
Konieczna
Lucyna
L
Oledzka
Ilona
I
Zarzycki
Paweł K
PK
Lamparczyk
Henryk
H
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
D013607:Tablets; D001418:Baclofen