title: Determination of imidol hydrochloride in human plasma and urine by high-performance liquid chromatography-tandem mass spectrometry and its application to clinical pharmacokinetic study.
abstract: 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 C₁₈ column (50 x 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.
authors.affiliation: School of Pharmacy, Shenyang Pharmaceutical University, Shenyang 110016, China.
authors.forename: Zhengyuan
authors.initials: Z
authors.lastname: Shi
authors.forename: Kaishun
authors.initials: K
authors.lastname: Bi
authors.forename: Yang
authors.initials: Y
authors.lastname: Li
authors.forename: Xin
authors.initials: X
authors.lastname: Hu
authors.forename: Kexin
authors.initials: K
authors.lastname: Li
authors.forename: Ping
authors.initials: P
authors.lastname: Gong
authors.forename: Xiaohui
authors.initials: X
authors.lastname: Chen
mesh_terms: D000998:Antiviral Agents / Q000097:blood* / Q000652:urine*; D002138:Calibration; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D006509:Hepatitis B / Q000188:drug therapy; D006801:Humans; D007211:Indoles / Q000097:blood* / Q000652:urine*; D012680:Sensitivity and Specificity; D013454:Sulfoxides / Q000097:blood* / Q000652:urine*; D053719:Tandem Mass Spectrometry / Q000379:methods
chemical_list: D000998:Antiviral Agents; D007211:Indoles; D013454:Sulfoxides; C571724:ethyl-6-bromo-5-hydroxy-4-(imidazol-1-yl)-methyl-1-methyl-2-(phenylsulfinylmethyl)-1H-indole-3-carboxylate