Pharmacokinetics and bioequivalence study of simvastatin orally disintegrating tablets in chinese healthy volunteers by LC-ESI-MS/MS

ISSN: 09750851
9Citations
Citations of this article
18Readers
Mendeley users who have this article in their library.

Abstract

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. © 2011 Ding MJ, et al.

Cite

CITATION STYLE

APA

Ding, M. J., Yuan, L. H., Li, Y., Wang, S., Wu, X. L., Liu, J., … Zhou, X. M. (2011). Pharmacokinetics and bioequivalence study of simvastatin orally disintegrating tablets in chinese healthy volunteers by LC-ESI-MS/MS. Journal of Bioequivalence and Bioavailability, 3(2), 32–37.

Register to see more suggestions

Mendeley helps you to discover research relevant for your work.

Already have an account?

Save time finding and organizing research with Mendeley

Sign up for free