VALIDATION METHOD FOR MEASURING SIMVASTATIN IN HUMAN PLASMA BY HPLC-UV AND ITS APPLICATION IN STUDY SIMVASTATIN STABILITY IN PLASMA AND WORKING SOLUTION

摘要

Objective : The aim of this study by HPLC-UV method for determination of simvastatin in human plasma has been developed, after extraction by ethyl acetate and hexane (90/10%, v/v) using lovastatin as internal standard. Methodology: Solutes are separated on a C 18 column with mobile phase consist a mixture of acetonitrile-water (51/49%, v/v) mL/min and UV detection at 238 nm. The calibration curve was linear from 20 to 1000 ng/mL (r = 0.9996). Result: The intra-day coefficients of variation were less than 6.00% and the accuracies were between 97.52 and 104.80% for human control plasma containing 50, 200 and 500 ng/mL of simvastatin, respectively. The inter-day coefficients of variation were less than 9.00% and the accuracies were between 101.65 and 105.16% for human control plasma containing 50, 200 and 500 ng/mL of simvastatin, respectively. The entire run time for analysis was only 11 min. The limit of quantitation of 20 ng/mL was achieved. Conclusion: The stability studies of simvastatin in human plasma for two months at -85 0 C, in acetonitrile and water for one month at 4 0 C, did not show any significant degradation