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KMID : 0614020040190010048
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Journal of Pharmaceutical Sciences (C.N.U.)
2004 Volume.19 No. 1 p.48 ~ p.51
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Bioavailability of Primidone in Healthy Korean Human Volunteers
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Kwon Kwang-II
Yun Min-Hyuk
Yun Hee-Yul
Park Hee-Chan
Kwon Jun-Tack
Shim Hee-Ok
Kim Dong-Chool
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Abstract
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A reversed phase HPLC method was developed and validated for the determination of primidone in human plasma. Propylthiouracil was used as an internal standard. Calibration curves were linear in the concentration range of 10-120 ng/㎖. The coefficient of variation of the intra- and inter-day precision were below 15%. The coefficient of variation of the accuracy were below 15% in the concentration range investigated. A bioavailability study was performed using the validated HPLC method. Twenty four healthy human male volunteers were orally administered 20 mg of primidone. The pharmacokinetic parameters were calculated using WinNonlin. The mean values of AUC_(LAST) was 85.0±17.7 ㎍ hr/㎖, C_(max) was 4.22±1.04 ㎍/㎖, T_(max) was 1.85±1.13 hr, t_(1/2) was 17.7±2.4 hr. The pharmacokinetic parameters and the HPLC method can be used for the desigm of bioequivalence study of primidone.
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KEYWORD
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primidone, pharmacokinetics, bioequivalence, bioavailability, HPLC
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