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

Author(s): Xue Min Zhou | 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

Journal: Journal of Bioequivalence & Bioavailability
ISSN 0975-0851

Volume: 3;
Issue: 2;
Start page: 032;
Date: 2011;
Original page

Keywords: Simvastatin | LC-ESI-MS/MS | Pharmacokinetics | Orally disintegrating tablets

A simple, rapid and sensitive liquid chromatography-electrospray ionization-tandem mass spectrometry (LC-ESI-MS/MS) assayfor the determination of simvastatin in human plasma using lovastatin as internal standard (IS) was established. After being extractedby methyl tert-butyl ether, solutes were separated on a C18 column with a mobile phase consisting of methanol-water-5M ammoniumacetate (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 alinear 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 extractionrecovery of simvastatin was over 92.48%. Intra- and inter-day variability values were less than 10.5% and 9.30%, respectively. Thismethod offered good precision and accuracy and was successfully applied for a bioequivalence studies of 20 mg of simvastatin orallydisintegrating tablets in 20 Chinese healthy volunteers
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