Session Speaker

Liquid Chromatography – Tandem Mass Spectrometry for the Simultaneous Quantitation of Artemether and Lumefantrine in Human Plasma: Application for a Pharmacokinetic Study
Isabela Costa César, José Antônio de Aquino Ribeiro, Leonardo de Souza Teixeira, Karini Bruno Bellorio, Fernanda Crunivel de Abreu, Josianny Mesquita Moreira, Paula Rocha Chellini and Gerson Antônio Pianetti
Brasil

Nowadays, malaria is the world’s most incident parasitic infection. Due to the wide spread of parasite resistance, artemisinin based combination therapy (ACT) have been advocated as a promising malaria treatment. Artemether-lumefantrine, a registered fixed dose combination (20+120 mg), is the most common ACT used in malaria endemic areas. A liquid chromatography-electrospray ionization tandem mass spectrometry (HPLC-ESI-MS/MS) method for the simultaneous quantitation of artemether and lumefantrine in human plasma was developed and validated. The analytes were extracted by a protein precipitation procedure and separated on a reversed-phase Zorbax SB-Ciano column with a mobile phase composed of methanol and 10 mM aqueous ammonium acetate. The method was properly validated and demonstrated to be selective, sensitive, precise, accurate and linear, with high recovery rates for both drugs. The method was applied to a pharmacokinetic study in six healthy volunteers. The mean C_max for artemether, 57.37 ng/ml, was reached 1.9 h (T_max) after drug administration, whereas for lumefantrine a C_max of 1979.95 ng/ml was reached after 5.8 h. The developed HPLC-ESI-MS/MS method showed to be simple, robust and suitable for routine high throughput analyses and may be successfully applied to pharmacokinetic and bioequivalence studies of artemether and lumefantrine in human subjects.