Among the tools to achieve the optimal treatment for malaria, it highlights the concentration monitoring of antimalarials in biological fluids. Considering that Coartem ® is used in first-line therapy for treatment of falciparum malaria, it is appropriate that this study aims to validate an analytical methodology for determination of lumefantrine in whole blood samples, adsorbed on filter paper, and in plasma by high performance liquid chromatography (HPLC) in patients with falciparum malaria uncomplicated, using liquid-liquid extraction. Were carried out studies of selectivity, linearity, calibration curve, limits of detection and quantification, recovery, intra and inter assay precision, stability and robustness. The samples for study of applicability of the proposed method, were collected from patients with falciparum malaria using Coartem ® (artemether-20mg + lumefantrine-120mg) on D3. The optimized chromatographic conditions were: wavelength 335nm, flow 1.2 mL / min. and a mobile phase consisting of acetonitrile-water (60:40, v / v) pH = 3,5. The liquid-liquid extraction can be efficient, because the average recovery was 101.3% for plasma and 84.3% for whole blood. The method was selective and linear in the concentration range of 160 to 1760ng/mL. The limits of detection and quantitation was 32ng/mL and 160ng/mL. The average coefficient of variation intra assay, plasma and whole blood, respectively, were 10.88 and 8.38% and inter assay of 13.21 and 11.78%. The compound proved to be stable in whole blood absorbed onto filter paper for 70 days. Modification of pH, flow and mobile phase composition did not significantly alter the resolution of the analytes, suggesting an adequate strength. The method proved effective in quantifying lumefantrine in whole blood samples from patients with falciparum malaria and the validation parameters are consistent with the recommendations of regulatory agencies in Brazil.
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