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KMID : 0614020050200010073
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Journal of Pharmaceutical Sciences (C.N.U.)
2005 Volume.20 No. 1 p.73 ~ p.77
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Bioavailability of Spironolactone in Healthy Korean Volunteers
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Shim Hee-Ok
Lee Sun-Young
Jee Ung-Kil
Kim Dong-Chool
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Abstract
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reversed phase HPLC method was developed and validated for the determination of spironolactone in human plasma. Fenoprofen was used as an internal standard. Calibration curves were linear in the concentration range of 2.5~200 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. Eight healthy male volunteers were orally administered 100 ㎎ of spironolactone. The pharmacokinetic parameters were calculated using WinNonlin. The mean values of AUC＿(12hr) was 158.9±69.9 ngㆍhr/㎖, C＿(max) was 42.2±14.9 ng/㎖, T＿(max)was 1.79±0.60 hr, t＿(1/2) was 2.72±0.87 hr. The pharmacokinetic parameters and the HPLC method can be used for the design of bioequivalence study of spironolactone.
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KEYWORD
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spironolactone, bioavailability, bioequivalence
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