Determination of loratadine in human plasma by HPLC with fluorescence detector and study on its bioavailability.
OBJECTIVE
To establish an HPLC-fluorescence method for determination of loratadine in human plasma and evaluate its relative bioavailability.


METHODS
An Alltech-C18 column and a mobile phase of acetonitrile-water-glacial acetic acid-triethylamine (90:100:6:0.15) were used. The fluorescence detector was set at Ex 274 nm, Em 450 nm. The flow rate was 1 mL.min-1.


RESULTS
The calibration curve was linear over a concentration range of 0.2-30 micrograms.L-1. The limit of quantification was 0.2 microgram.L-1. The average method recoveries varied from 96% to 98%. The results showed AUC, Tmax, Cmax and T1/2 beta between the testing tablets, testing capsules and reference tablets had no significant difference (P > 0.05). Relative bioavailabilities were 107% +/- 17% and 100% +/- 14% respectively.


CONCLUSIONS
The three formulations were bioequivalent.
Xu
Xiao-jie
XJ
Center for Instrumental Analysis of China Pharmaceutical University, Nanjing 210009, China.
Shang
Er-xin
EX
Qiu
Fu-rong
FR
Mao
Guo-guang
GG
Xiang
Bing-ren
BR
D019540:Area Under Curve; D001682:Biological Availability; D002851:Chromatography, High Pressure Liquid / Q000379:methods; D005453:Fluorescence; D039563:Histamine H1 Antagonists, Non-Sedating / Q000097:blood / Q000493:pharmacokinetics*; D006801:Humans; D017336:Loratadine / Q000097:blood / Q000493:pharmacokinetics*; D008297:Male
D039563:Histamine H1 Antagonists, Non-Sedating; D017336:Loratadine