|
KMID : 0370020010150000075
|
|
Chung-Ang Journal of Pharmacal Sciences
2001 Volume.15 No. 0 p.75 ~ p.85
|
|
|
Determination of Cilostazol in Human Plasma and Bioequivalence of Its Preparations
|
|
|
|
|
Abstract
|
|
|
Cilostazol has both antithrombotic and cerebral vasodilating effects, and one of the mechanism is the selective inhibition of platelet cyclic AMP phosphodiesterase. A fast short-step and simple method for determining of cilostazol in human plasms has been developed and validated. The procedure was linear in the range from 0.05 to 2ug/ml for cilostazol. 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 cilostazol tablets, Pletaal^TM and Stazol^TM was evaluated according to the guidlines of Korea Food and Drug Administration (KFDA). Sixteen healthy male volunteers, 64.6±5.9kg in body weight and 23.2±1.5 yr in age, were divided into two groups and a randomized 2×2 cross-over study was employed. After two tablets containing 50mg of cilostazol were orally administered, blood samples were taken at the predetermined time intervals. The concentrations of cilostazol in plasma were determined by liquid-liquid extraction 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 the parameters.
The results were revealed that the differences in AUC, C_max and T_max between two tablets were 7.903%, 1.100% and 10.654%, 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 Stazol^TM tablet is bioequivalent to Pletaal^TM tablet.
|
|
|
KEYWORD
|
|
|
|
|
|
FullTexts / Linksout information
|
|
|
|
|
|
Listed journal information
|
|
|
|
|