High-performance liquid chromatographic method for the bioequivalence evaluation of desloratadine fumarate tablets in dogs.
A simple HPLC method was developed for the determination of desloratadine in dog plasma and was used for evaluating the bioequivalence of desloratadine fumarate tablets and desloratadine tablets in dogs. Chromatographic separation was performed on a Hypersil CN column (150 mm x 5.0 mm, 5 microm) using a mixture of methanol, acetonitrile and phosphate buffer (pH 5.5; 0.01 mol/l) (35:35:30, v/v/v) as mobile phase delivered at a flow rate of 0.8 ml/min. The detection was set at 241 nm. The limit of quantitation was 5.0 ng/ml. The calibration range was from 5.0 to 800.0 ng/ml. Inter- and intra-day precision ranged from 1.8 to 3.8% and from 2.2 to 9.0%, respectively. The recovery of desloratadine from dog plasma ranged from 78.8 to 82.0%. The developed method was applied to the bioequivalence studies of desloratadine fumarate tablets (test preparation) and desloratadine tablets (reference preparation) in five dogs. Pharmacokinetic parameters t(max), C(max), AUC(0-t), AUC(0- infinity ), t(1/2) were determined from plasma concentration-time profiles of both preparations. The analysis of variance (ANOVA) did not show any significant difference between the two preparations and 90% confidence intervals fell within the acceptable range for bioequivalence. Based on these statistical inferences it was concluded that the two preparations exhibited comparable pharmacokinetic profiles and that desloratadine fumarate tablets was bioequivalent to desloratadine tablets.
Liu
Lihe
L
School of Pharmacy, Shenyang Pharmaceutical University, Shenyang, PR China.
Qi
Meiling
M
Wang
Peng
P
Li
Haozhi
H
D000818:Animals; D002851:Chromatography, High Pressure Liquid / Q000379:methods; D018592:Cross-Over Studies; D004285:Dogs; D004353:Drug Evaluation, Preclinical / Q000379:methods; D005650:Fumarates / Q000032:analysis* / Q000493:pharmacokinetics*; D017336:Loratadine / Q000031:analogs & derivatives* / Q000032:analysis* / Q000493:pharmacokinetics*; D013607:Tablets; D013810:Therapeutic Equivalency
D005650:Fumarates; D013607:Tablets; D017336:Loratadine; C032005:fumaric acid; C121345:desloratadine