Desenvolvimento e otimização de um método cromatográfico para a determinação de fármacos hipolipidêmicos

Abstract

Currently the number of people who develop hypercholesteraemia has been growing (increase in blood of LDL-cholesterol levels), increasing the use of drugs in the treatment of patients who have this pathology. The most used hypolipidaemic agents in treatment are fibric acids derivatives and statins. In this sense, the objective of this work was develop and validate of an analytical methodology for determination of ciprofibrate and simvastatin alone or in combination in pharmaceutical formulations using High Performance Liquid Chromatographic (HPLC) technique with UV detection. Chromatographic conditions were optimized through design factorial starting from which the best separation results were reached with C -18 (150 mm x 4,6 mm) column, isocratic elution, mobile phase constituted of acetonitrile: methanol: water (50: 30: 20), flow rate of 0.8 mL min-1 at 40 ° C and detection at 238 nm. The proposed methodology was validated according to ANVISA guidelines: specificity, linearity, limits of detection (LOD) and quantification (LOQ), precision, accuracy and robust, being obtained results inside of the recommended standards. Therefore, the proposed method was linear, precise, accurate and appropriate for the determination of ciprofibrate and simvastatin in pharmaceutical formulations and it may be used in the routine of quality control laboratories.