| 지원과제 |
RCTC, BMRC |
| 저자명 |
Ku HY, Shon JH, Liu KH, Shin JG, Bae SK |
| 학회정보 |
J Chromatogr B Analyt Technol Biomed Life Sci. 877(1-2):95-100, 2009 Jan |
| 제 목 |
Liquid chromatography/tandem mass spectrometry method for the simultaneous determination of vardenafil and its major metabolite, N-desethylvardenafil, in human plasma: Application to a pharmacokinetic study |
| LINK |
www.ncbi.nlm.nih.gov/pubmed/19042162 |
| 게시일 |
2009-02-16 10:58:24 |
| 년도 |
|
| 내용 |
A rapid and sensitive LC-MS/MS method for the determination of vardenafil and its major metabolite, N-desethylvardenafil, in human plasma using sildenafil as an internal standard was developed and validated. The analytes were extracted from 0.25-mL aliquots of human plasma by liquid-liquid extraction, using 1mL of ethyl acetate. Chromatographic separation was carried on a Luna C(18) column (50mmx2.0mm, 3mum) at 40 degrees C, with an isocratic mobile phase consisting of 10mM ammonium acetate (pH 5.0) and acetonitrile (10:90, v/v), a flow rate of 0.2mL/min, and a total run time of 2min. Detection and quantification were performed using a mass spectrometer in the selected reaction-monitoring mode with positive electrospray ionization at m/z 489.1-->151.2 for vardenafil, m/z 460.9-->151.2 for N-desethylvardenafil, and m/z 475.3-->100.1 for the internal standard (IS), respectively. This assay was linear over a concentration range of 0.5-200ng/mL with a lower limit of quantification of 0.5ng/mL for both vardenafil and N-desethylvardenafil. The coefficient of variation for the assay precision was <13.6%, and the accuracy was >93.1%. This method was successfully applied to a pharmacokinetic study after oral administration of vardenafil 20mg tablet in Korean healthy male volunteers. |
