Journal of Bioequivalence & Bioavailability

Abstract

Pharmacokinetics and Bioequivalence Study of Simvastatin Orally Disintegrating Tablets in Chinese Healthy Volunteers by LC-ESI-MS/MS

Mei Juan Ding, Li Hua Yuan, Yun Li, Shu Wang, Xiao Li Wu, Jie Liu, Kun Fang Ma, Hong Wei Fan, Zhen Yu Lu, Hui Juan Xu and Xue Min Zhou

A simple, rapid and sensitive liquid chromatography-electrospray ionization-tandem mass spectrometry (LC-ESI-MS/MS) assay for the determination of simvastatin in human plasma using lovastatin as internal standard (IS) was established. After being extracted by methyl tert-butyl ether, solutes were separated on a C18 column with a mobile phase consisting of methanol-water-5M ammonium acetate (90:10:0.1, v/v/v). The quantification of target compounds was carried out by using multiple reaction monitoring (MRM) mode: m/z 419.2 ? 199.1 and 405.1 ? 285.1 for simvastatin and IS, respectively. The method had a run time of 3.3 min and a linear calibration curve in the range of 0.1-20 ng/ml. The lower limit of quantification (LOQ) was about 0.1 ng/ml. The mean extraction recovery of simvastatin was over 92.48%. Intra- and inter-day variability values were less than 10.5% and 9.30%, respectively. This method offered good precision and accuracy and was successfully applied for a bioequivalence studies of 20 mg of simvastatin orally disintegrating tablets in 20 Chinese healthy volunteers.