VALIDATION METHOD FOR MEASURING SIMVASTATIN IN HUMAN PLASMA BY HPLC-UV AND ITS APPLICATION IN STUDY SIMVASTATIN STABILITY IN PLASMA AND WORKING SOLUTION
Abstract
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 C18 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 -850C, in acetonitrile and water for one month at 40C, did not show any significant degradation.
Â
Key words
HPLC-UV, simvastatin and human plasma
Downloads
Published
How to Cite
Issue
Section
The publication is licensed under CC By and is open access. Copyright is with author and allowed to retain publishing rights without restrictions.