Development and optimization of chromatographic method for determination of hypolipidemic drugs in pharmaceutical formulations

Currently the number of people who develop hypercholesterolemia is raising (increase in blood LDL-cholesterol levels) increasing the use of drugs in treatment of patients who have this pathology. The most used hypolipidemics agents in treatment are fibric acid derivatives and statins1. In this work we propose the development of a methodology from simultaneous determination and quantification the ciprofibrate and simvastatin in pharmaceuticals formulations using the HPLC technique with detection UV. The methodology of HPLC in reverse phase and isocratic elution with mobile phase constituted of acetonitrile: methanol: water (50:30:20). The experimental conditions were optimized through experimental design. With the optimized conditions, it can be verified that there was an optimal separation of the drugs according to Figure 1. Analytical curves from the standard solution of ciprofibrate and simvastatin in the concentration range of 0,5 – 10 μgmL-1 were obtained with excellent linear correlation (r = 0,9999). The proposed method was applied in drugs determination in commercial samples with recovery rates ranging from 97 to 103 %. The validation considering the parameters of merit recommended by ANVISA allowed to verify that the proposed method is safe and reliable, being possible to use the HPLC technique with UV detection for the determination of ciprofibrate and simvastatin in pharmaceutical formulations.