Relative bioavailability of three formulations of citalopra hydrobromide in Chinese healthy volunteers
- VernacularTitle:三种西酞普兰制剂在中国健康男性体内的生物等效性
- Author:
Li NI
;
Xiaomei CAO
;
Jinheng LI
;
Minhong CAI
- Publication Type:Journal Article
- Keywords:
citalopra hydrobromide;
HPLC-UV;
pharmacokinetics;
relative bioavailability
- From:
Chinese Journal of Clinical Pharmacology and Therapeutics
2004;0(09):-
- CountryChina
- Language:Chinese
-
Abstract:
AIM:To study the pharmacokinetics and relative bioavailability of citalopra hydrobromide in human plasma.METHODS:The citalopra hydrobromide concentrations in plasma were determined by HPLC-UV.The column was Lichrospher ODS(5 ?m,250 mm?4.6 mm).The mobile phase was acetonitrile-0.1 mol/L KH2PO4 buffer-triethylamine(35:65:0.3,v/v/v).The flow rate was 1 mL/min.The detection wavelength was 240 nm.The test and reference formulations of citalopra were given to 18 healthy male volunteers.RESULTS:The calibration curve was linear within the range of 2-128 ?g/L,r=0.9992.The minimum detection limit was 1 ?g/L.The recovery was 80%-88%,the RSDs of inter-day and intra-day were not more than 15%.After a single oral dose of 20 mg citalopra hydrobromide was given,the main pharmacokinetic parameters tmax were(4.6?1.0),(4.4?1.4) and(4.0?1.4) h;Cmax were(70?19),(71?17) and(66?21) ?g/L;and t1/2 were(37?9),(37?6) and(36?6) h respectively.CONCLUSION:No significant difference exists among the pharmacokinetic parameters of the three formulations.They are bioequivalent.