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KMID : 0614020060210010045
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Journal of Pharmaceutical Sciences (C.N.U.)
2006 Volume.21 No. 1 p.45 ~ p.49
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LC/MS Analysis and Pharmacokinetic of Tacrolimus in Human Volunteers
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Yun Min-Hyuk
Lee Seo-Pan
Nam Jin-Kyung
Kwon Kwang-II
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Abstract
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The purpose of this study was to confirm the analysis method and also to estimate the pharmacokinetic parameters of tacrolimus in human volunteers. The pharmacokinetics of tacrolimus tablet was examined on 24 healthy volunteers who received a single oral dose(4mg) of each preparation in the fasting state. After an oral dosing, blood samples were collected for a period of 72 hours. Blood concentrations of tacrolimus were determined using a liquid chromatographic electrospray mass spectrometric (LC-MS) method. The pharmacokinetic parameters were calculated with non-compartmental(AUC, C_(max), T_(max), Cl_(t), V/F) and compartmental(K_(el), K_(a), K_(12), K_(21), t_(1/2)) pharmacokinetic analysis using WinNonlin program. The estimated means of AUC_(0-72hours), C_(max) and T_(max) were 425.54 ± 197.49 ng·hr/ml, 76.14 ± 29.18 ng/ml and 1.40 ± 0.44 hr, respectively. The means of other pharmacokinetic parameters(V/F, CL_(t), K_(el), K_(a), K_(23), K_(32) and t_(1/2)) were 35.12 ± 34.28 L, 10.45 ± 5.32 L/hr, 0.39 ± 0.21 hr^(-1), 1.91 ± 4.17 hr^(-1), 0.32 ± 0.33 hr^(-1), 0.07 ± 0.09 hr^(-1), 26.94 ± 10.19 hr^(-1), respectively.
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KEYWORD
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Tacrolimus, LC-MS, pharmacokinetic, WinNonlin
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