Determination of finasteride in human plasma and its pharmacokinetics and relative bioavailability by HPLC-electrospray mass spectrometry
- VernacularTitle:LC-ESI-MS法测定人血浆非那雄胺的浓度及其药动学
- Author:
Jianhua LI
;
Xuelan GU
;
Yiqun XU
;
Jing WANG
;
Liqing WU
;
Jiahui CHEN
;
Jianjun ZOU
;
Yubing ZHU
;
Hongwei FAN
;
Dawei XIAO
- Publication Type:Journal Article
- Keywords:
finasteride;
pharmacokinetics;
bioavailability;
chromatography,high pressure liquid;
spectrometry,mass,electrospray ionization
- From:
Chinese Journal of New Drugs and Clinical Remedies
2006;25(7):537-541
- CountryChina
- Language:Chinese
-
Abstract:
AIM: A new HPLC-MS method was developed to determine finasteride in human plasma. METHODS: Two formulations of finasteride tablets were given to 20 healthy male volunteers according to a randomized 2-way cross-over design. The samples were extracted by ethyl acetate under basic conditions, then were separated by C18 column and determined by mass detector. RESULTS: The calibration curve of finasteride was linear and intra-day and inter-day RSD were less than 10 %. The pharmacokinetics parameters of the two formulations (4.5 ± 0.5) h for t1/2; (3.0 ± 0.7) and (2.8 ± 0.9) h for tmax, respectively. The results indicated that there was no significant difference on cmax, A UC0-24, t1/2 or tmax values between the two formulations. CONCLUTION: The relative bioavailability of tablets I with respect to tablets Ⅱ is (99.3 ± 9.2) % by the A UC0-24 measurement, and bioe quivalence is observed between the two tablets.
