Bioequivalence study of simvastatin tablets in healthy Chinese volunteers by UPLC-MS/MS

Objective To develop an ultra performance LC-tandem mass spectrometry(UPLC-MS/MS) method to study the pharmacokinetics and bioequivalence of simvastatin tablets in human.MethodsA single oral dose of 40 mg simvastatin tablets(test preparation and reference preparation) were administrated to 18 healthy male volunteers according to a randomized cross design.The concentration of simvastatin in the plasma was determined by UPLC-MS/MS after a simple liquid-liquid extraction.ResultsThe linear calibration curve of simvastatin was obtained at 0.134~17.920 ng·mL-1.The intraday and interday precision was less than 7.3%.The pharmacokinetic parameters of the test preparation and reference preparation were as follows: AUC0~12 was(37.321±16.411) and(36.213±15.374)ng·h·mL-1;Cmax was(9.585±5.225) and(9.582±4.513) ng·mL-1,and tmax was(1.86±0.56) and(1.81±0.64)h,respectively.The relative bioavailability of the test preparation was(103.02±13.79)%.ConclusionThis method is rapid,highly sensitive and accurate,and suitable for the pharmacokinetic study of simvastatin.The two preparations are bioequivalent.