1.Clinic Pharmacology Laboratory，Affiliated Hospital Nanjiang 210029，China；2.Nanjing University of Traditional Chinese Medicine，Nanjing 210002，China
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History+
Received
Published
2007-12-26
2008-11-05
Issue Date
2008-11-05
Abstract
OBJECTIVE To study the pharmacokinetics and bioequivalence of valaciclovir in human.METHODS Twenty volunteers orally took the valaciclovir tablets with 2-way crossover design.The concentration of acyclovir,the metabolite of valaciclovir in plasma,was determined by HPLC-MS.The pharmacokinetic parameters were calculated by BAPP software.RESULTS The calibration curve was linear in the range from 41.6 to 5.34×103 μg·L-1.The relative recovery was more than 96.7%.The intra-and inter-RSDs were less than 10.2%.The main pharmacokinetic parameters of t1/2,ρmax,tmax and AUC0-14 for the test tablet were(3.21±0.29) h,(2.83×103±7.76×102) μg·L-1,(1.5±0.6) h and(1.02×104±2.03×103) μg·h·L-1,respectively.The pharmacokinetic parameters of t1/2,ρmax,tmax and AUC0-14 for the reference tablet were(3.23±0.30) h,(2.72×103±8.50×102) μg·L-1,(1.5±0.6) h and(9.91×103±2.46×103) μg·h·L-1,respectively.The relative bioavailability of the test tablet was(104.5±14.0)%.CONCLUSION The HPLC-MS method for the determination of acyclovir in plasma was proved to be sensitive,accurate and convenient.The reference and test tablets were bioequivalent.
CHEN Min;XU Mei-jun;ZHNG Jun;JU Wen-zheng;TN Heng-shn;LIU Fng.
Bioequivalence Study of Valaciclovir in Human by HPLC-MS Assay [J]. Chinese Pharmaceutical Journal, 2008, 43(21): 1647-1650
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