Determination Of Simvastatin In Human Plasma Using Ultra-Performance Liquid Chromatography-Tandem Mass Spectrometry

A rapid, sensitive and specific method has been developed for the determination of simvastatin in human plasma with ultra-performance liquid chromatography-tandem mass spectrometry. Simvastatin and the internal standard (lovastatin) were extracted from human plasma with diethyl ether-n-hexane-isopropanol (80: 20: 3, v/v/v) , then separated on a Waters ACQUITY UPLC (TM) BEH C-18 column (50 mm x 2. 1 mm, 1. 7 pLm) with isocratic elution at a flow rate of O. 25 mL/min. The mobile phase was composed of 85% acetonitrile and 15% water (containing 10 mmol/L ammonium acetate). Electrospray ionization (ESI) source was applied and operated in positive ion mode. Multiple reaction monitoring (MRM) mode with the transitions of m/z 419. 2 -> m/z 199. 0 and m/z 405. 0 m/z 199. 0 was used to quantify simvastatin and the internal standard, respectively. The linear calibration curve was obtained in the concentration range of 0. 051- 20. 4 ng/mL. The lower limit of quantification was 0. 051 ng/mL. The inter-day and intra-day precision (relative standard deviation) were less than 10%, and the accuracy (relative error) was within -2. 7% -0% calculated from quality control samples. The mean extraction recovery of simvastatin was 91. 6%. The method was proved to be selective, sensitive, rapid and suitable for the pharmacokinetic study of simvastatin.