用LCMS对西伐他汀在人体血浆中的药代动力学研究
Simple, sensitive and rapid LC–MS/MS method for the quantitation of cerivastatin in human plasma—application to pharmacokinetic studies
I) in human plasma, a potent hydroxy-methylglutaryl-coenzyme A reductase inhibitor. The analyte and internal standard (atorvastatin, II)
were extracted by liquid/liquid extraction with diethyl ether/dichloromethane (70/30, v/v). The chromatographic separation was performed
on reverse phase Xterra ODS column with a mobile phase of water/acetonitrile (30/70, v/v) with 0.03% formic acid. The protonated analyte
was quantitated in positive ionization by multiple reaction monitoring with a mass spectrometer. The mass transitions m/z 460.4→356.3 and
559.2→440.3 were used to measure I and II, respectively. The lower limit of quantitation was 10 pg/mL with a relative standard deviation
of less than 15%. Acceptable precision and accuracy were obtained for concentrations over the calibration curve ranges (0.01–10 ng/mL).
Sample analysis time of 2 min for each sample made it possible to analyze a throughput of more than 400 human plasma samples per day.
The assay can be used to analyze human plasma samples to support phase I and II clinical studies.