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Determination of imidol hydrochloride in human plasma and urine by high‐performance liquid chromatography–tandem mass spectrometry and its application to clinical pharmacokinetic study
Author(s) -
Shi Zhengyuan,
Bi Kaishun,
Li Yang,
Hu Xin,
Li Kexin,
Gong Ping,
Chen Xiaohui
Publication year - 2012
Publication title -
biomedical chromatography
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.4
H-Index - 65
eISSN - 1099-0801
pISSN - 0269-3879
DOI - 10.1002/bmc.1687
Subject(s) - chromatography , chemistry , pharmacokinetics , selected reaction monitoring , tandem mass spectrometry , mass spectrometry , extraction (chemistry) , liquid chromatography–mass spectrometry , triple quadrupole mass spectrometer , high performance liquid chromatography , pharmacology , medicine
Imidol hydrochloride is a novel drug for the treatment of hepatitis B virus infection. A simple, special and sensitive solid‐phase extraction liquid chromatography–tandem mass spectrometry method for determination of imidol in human plasma and urine was developed for the first time and applied to a pharmacokinetic study. The chromatographic separation was achieved on a C 18 column (50 × 2.1 mm, 3.5 µm) using gradient elution with acetonitrile and water both containing 0.1% acetic acid at a flow rate of 0.25 mL/min. The detection was performed on a triple quadrupole tandem mass spectrometer by multiple reaction monitoring mode via a positive eletrospray ionization source. The mass transition pairs of m / z 517.8 → 325 and m / z 298 → 174 were used to detect imidol and the (−)‐clausenamide (internal standard), respectively. The retention times of imidol and (−)‐clausenamide were 2.5 and 2.7 min, respectively. Linearity, accuracy, precision, recovery, matrix effect, dilution test and stability were evaluated during method validation over the range of 0.2–500 ng/mL in human plasma and 0.5–500 ng/mL in urine. The method was successfully applied to a clinical pharmacokinetic study of imidol in healthy volunteers following oral administration. Copyright © 2011 John Wiley & Sons, Ltd.