Pharmacokinetics and Bioequivalence Study of Simvastatin Orally Disintegrating Tablets in Chinese Healthy Volunteers by LC-ESI-MS/MS
Mei Juan Ding · Journal of Bioequivalence & Bioavailability · 2011
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 C 18 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.