Determination of bevantolol enantiomers in human plasma by coupled achiral-chiral high performance-liquid chromatography.
A coupled achiral-chiral high performance liquid chromatographic method was developed and fully validated for the determination of bevantolol enantiomers, (-)-(S)-bevantolol and (+)-(R)-bevantolol, in human plasma. Plasma samples were prepared by solid phase extraction with Sep-Pak Plus C18 cartridges followed by HPLC. Bevantolol enantiomers and (+)-(R)-Propranolol as internal standard (IS) were preseparated from interfering components in plasma on a Phenomenex silica column and bevantolol enantiomers and IS were resolved and determined on a Chiralcel OJ-H chiral stationary phase. The two columns were connected by a switching valve equipped with silica precolumn. The Precolumn was used to concentrate bevantolol in the eluent from the achiral column before back flushing onto chiral phase. A detailed validation of the method was performed accordingly to FDA guidelines. For each enantiomer the assay was linear between 20 and 1600 ng/ml. The quantification limits of both bevantolol enantiomers were 20 ng/ml. The intraday variation was between 1.07 and 12.64% in relation to the measured concentration and the interday variation was 0.91 and 11.79%. The method has been applied to the determination of (-)-(S)- and (+)-(R)-bevantolol in plasma from healthy volunteers dosed with racemic bevantolol hydrochloride.
Oh
Joung Weon
JW
College of Pharmacy, Kangwon National University, Chuncheon, Republic of Korea.
Trung
Tran Quoc
TQ
Sin
Kwan Seog
KS
Kang
Jong Seong
JS
Kim
Kyeong Ho
KH
D002851:Chromatography, High Pressure Liquid / Q000295:instrumentation / Q000379:methods* / Q000706:statistics & numerical data; D004355:Drug Stability; D006801:Humans; D011412:Propanolamines / Q000097:blood* / Q000737:chemistry / Q000493:pharmacokinetics; D012680:Sensitivity and Specificity; D013237:Stereoisomerism
D011412:Propanolamines; C021148:bevantolol