Validation Method for Measuring Simvastatin in Human Plasma by Hplc-uv and Its Application in Study Simvastatin Stability in Plasma and Working Solution
Year: 2014
Type: article
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.
Author: Khaled Mohammed Alakhali
Language: English
Subfield: Analytical Chemistry
Field: Chemistry
Domain: Physical Sciences
Open Access status: diamond
OpenAlex ID: W2124726036