High-performance liquid chromatographic-tandem mass spectrometric method for the determination of clemastine in human plasma.
A highly sensitive high-performance liquid chromatographic-tandem mass spectrometric method (HPLC-MS-MS) has been developed to quantitate clemastine in human plasma for the purpose of pharmacokinetic studies. Sample preparation was carried out by liquid-liquid extraction using deuterated clemastine as an internal standard. Chromatographic separation used a C18 reversed phase polymer column giving an extremely fast total run time of 2 min. The method was validated and used for the bioequivalence study of clemastine tablets in healthy male volunteers (n=28). The lower limit of detection proved to be 0.01 ng/ml for clemastine.
Horváth
Viola
V
Research Group of Technical Analytical Chemistry, Hungarian Academy of Sciences-Budapest University of Technology and Economics, Gellért tér 4., Budapest H-1111, Hungary. vhorvath@mail.bme.hu
Tolokán
Antal
A
Egresi
Andrea
A
Pap
Tímea
T
Horvai
George
G
Balogh-Nemes
Katalin
K
Klebovich
Imre
I
D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D002974:Clemastine / Q000097:blood* / Q000493:pharmacokinetics; D003903:Deuterium; D004355:Drug Stability; D006634:Histamine H1 Antagonists / Q000097:blood* / Q000493:pharmacokinetics; D006801:Humans; D008297:Male; D012015:Reference Standards; D015203:Reproducibility of Results; D021241:Spectrometry, Mass, Electrospray Ionization / Q000379:methods; D013810:Therapeutic Equivalency
D006634:Histamine H1 Antagonists; D002974:Clemastine; D003903:Deuterium