|
KMID : 0370020000140000039
|
|
Chung-Ang Journal of Pharmacal Sciences
2000 Volume.14 No. 0 p.39 ~ p.47
|
|
|
Determination of Triflusal in human plasma and Bioequivalence of Triflusal Preparations
|
|
|
|
|
Abstract
|
|
|
|
Triflusal is an inhibitor of platelet aggregation structurally related to the salicylate group. Triflusal and its active metabolite 2-hydroxy-4-trifluoromethyl benzoic acid (HTB) have platelet antiaggregant effect. A fast short-step and simple method for determining of triflusal in human plasma has been developed and validated. The procedure was linear in the range from 0.1 to 5 ug/ml for triflusal. The intraday and interday validation for coefficient of variance (CV, %) and relative error (RE) were less than ±15%. Based on this analysis method, the bioequivalence of two triflusal capsules, Disgren^TM and Tris^TM was evaluated according to the guidlines of Korea Food and Drug Administration (KFDA). Sixteen healthy male volunteers, 66.25±6.82kg in body weight and 23.25±1.48 in age, were divided into two groups and a randomized 2×2 cross-over study was employed. After one capsule containing 300mg of triflusal was orally administered, blood samples were taken at the predetermined time intervals and the concentrations of triflusal in plasma were determined by protein precipitation method using HPLC with UV detector. Pharmacokinetic parameters such as AUC, C_max and T_max were calculated and ANOVA was employed for the statistical analysis of parameters. The results were revealed that the differences in AUC, C_max and T_max between two capsules were 2.58%, -0.74% and 17.09%, respectively. The power (1-β) for AUC and C_max were above than 80%. Minimum detectable differences (Δ) at α=0.1 and 1-β=0.8 and 90% confidence intervals for AUC and C_max were all less than ±20. All of the above mentioned parameters met the criteria of KFDA guidlines for bioequivalence, indicating that Tris^TM capsule is bioequivalent to Disgren^TM capsules.
|
|
|
KEYWORD
|
|
|
|
|
|
FullTexts / Linksout information
|
|
|
|
|
|
Listed journal information
|
|
|
|
|