Determination of levofloxacin concentration in plasma of Chinese healthy volun-teers by HPLC with fluorescence detection and bioequivalence study of levofloxa-cin hydrochloride tablets
10.3969/j.issn.1006-0111.2016.05.012
- VernacularTitle:高效液相色谱荧光法测定血浆中左氧氟沙星的浓度及其生物等效性研究
- Author:
Xiaoying YANG
1
;
Wenping ZHANG
;
Xinyu WANG
;
Hongwan DANG
Author Information
1. 宁夏医科大学总医院 药剂科
- Keywords:
levofloxacin;
HPLC;
bioequivalence
- From:
Journal of Pharmaceutical Practice
2016;34(5):428-430,440
- CountryChina
- Language:Chinese
-
Abstract:
Objective To develop a HPLC-fluorescence method to determine levofloxacin concentration in plasma for studying bioequivalence of levofloxacin hydrochloride tablet in Chinese healthy volunteers .Methods A single-dose of 0 .2 g test or reference preparation was given to 24 healthy volunteers in a randomized crossover study .The concentrations of levofloxacin at different time points were determined by HPLC with fluorescence detection .The pharmacokinetic parameters were calculated using DAS 2 .0 software program .Results The main pharmacokinetic parameters of the test and reference preparation ,t 1/2 、tmax 、ρmax 、AUC0-36 and AUC0-inf ,were respectively (6 .71 ± 0 .95) h and (6 .60 ± 1 .00) h ,(0 .85 ± 0 .30) h and (0 .79 ± 0 .28) h , (2 815 .48 ± 513 .04 ) ng/ml and (3 185 .59 ± 674 .29 ) ng/ml ,(17 157 .61 ± 1 949 .07 ) ng · h/ml and (17 425 .06 ± 2 447 .80) ng · h/ml ,(18 324 .52 ± 2 019 .41) ng · h/ml and (18 540 .41 ± 2 523 .08) ng · h/ml .The statistical analysis showed that the main pharmacokinetic parameters between test and reference preparations were no significant differences .The 90% confidence interval of test and reference preparations AUC 0-36 、AUC0-inf and ρmax were 95 .2% ~102 .5% 、96 .1% ~102 .2%and 82 .8% ~94.9% .Conclusion The test and reference preparations were bioequivalent .
