Title: Determination of simvastatin in human plasma by HPLC-MS/MS and bioequivalence study in healthy volunteers
Abstract: Objective To improve the determination of human plasma simvastatin,study the relative bioavailability of Simvastatin tablets,and evaluate the bioequivalence.Methods A single oral dose of 40 mg test and reference formulations was given to 20 healthy volunteers in a randomized cross-over study.Sample(0.2 mL) was determined by HPLC-MS/MS after being extracted by 1 mL diethyl ether.DAS 2.0 was used to assess the relative bioavailability and bioequivalence of Simvastatin tablets.Results The linear range of the calibration curves was 0.1~20 ng·mL-1 for simvastatin with a lower limit of quantitation(0.1 ng·mL-1).Within-and between-run precision was less than 6%.Accuracy ranged from 101% to 109%.The recovery was more than 82%.The main pharmacokinetic parameters t1/2,tmax,Cmax,AUC0~t and AUC0~∞ of the two formulations were as follows:(5.3±5.1)h,(2.2±0.7)h,(4.6±3.0)ng·mL-1,(24.3±15.7) ng·h ·mL-1,(27.5±21.6) ng·h ·mL-1 and(4.5±6.7)h,(1.9±0.7)h,(5.0±3.0) ng·mL-1,(21.4±13.4) ng·h ·mL-1,(23.9±21.2) ng·h ·mL-1.Relative bioavailability of Simvastatin test reference was 113.1%±17.4%.Conclusion The present method is sensitive and reliable.The method described herein has been successfully used for the bioequivalence study of simvastatin formulation.The test and reference simvastatin tablets are bioequivalent.
Publication Year: 2009
Publication Date: 2009-01-01
Language: en
Type: article
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