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KMID : 0043320110340010059
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Archives of Pharmacal Research
2011 Volume.34 No. 1 p.59 ~ p.69
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simultaneous determination of mycophenolic acid and its metabolites by HPLC and pharmacokinetic studies in rat plasma and bile
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Gao Jun wei
Peng Zhi Hai
Li Xiao Yu
Sun Bo
Guo Yan Kun
Liu Gao Lin
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Abstract
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In this study, we determined the pharmacokinetics of mycophenolic acid (MPA) and its metabolites mycophenolic acid glucuronide (MPAG) and acyl glucuronide (AcMPAG) in rat plasma and bile, using a newly developed HPLC method. Protein precipitation and liquid-liquid extraction were employed in sample preparation of plasma and bile, respectively. The HPLC methods included a gradient elution consisting of acetonitrile and phosphate buffer at a flow rate of 1.2 mL/min, with UV detection at 254 nm. The HPLC method was found to be sensitive and linear (r2 ≥ 0.9991, 1.0?128.0 and 0.25?32.0 mg/L for MPA; 1.0?128.0 and 0.5?64.0 mg/L for MPAG; 0.25?32.0 and 1.0?128.0 mg/L for AcMPAG in rat plasma and bile, respectively), precise (both the intra- and inter-day variability were ≤ 6.8%), and accurate (both the intra- and inter-day accuracy were between 92.2% and 105.4%). The average extraction efficiencies for MPA, MPAG and AcMPAG were 85.3%, 100.1%, and 94.7% in plasma, and 88.0%, 67.3%, and 68.3% in bile, respectively. The method was successfully employed for pharmacokinetic studies in plasma and bile after oral administration of mycophenolate mofetil (prodrug of MPA) in rats.
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KEYWORD
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Mycophenolic acid, Mycophenolic acid glucuronide, Mycophenolic acid acyl glucuronide, Pharmacokinetics
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