ANALYTICAL METHOD DEVELOPMENT VALIDATION FOR SIMULTANEOUS DETERMINATION OF ARTEMETHER AND LUMEFANTRINE IN BULK AND PHARMACEUTICAL DOSAGE FORM BY USING RP-HPLC

A new  simple, accurate, economic, rapid and precise reverse phase high performance liquid chromatographic method has been developed for the validated of Artemether and Lumefantrine, in its pure form as well as in pharmaceutical dosage form. Chromatography was carried out on X bridge C18 (4.6×150mm) 5 µ column using a mixture of Methanol: Phosphate Buffer pH-3.6 (30:70v/v) as the mobile phase at a flow rate of 1.0ml/min, the detection was carried out at 260nm. The retention time of the Artemether and Lumefantrine was 2.669, 3.855±0.02min respectively. The method produce linear responses in the concentration range of 10-50µg/ml of Artemether and 10-50µg/ml of Lumefantrine. The method precision for the determination of assay was below 2.0%RSD. The method is useful in the quality control of bulk and pharmaceutical formulations.

Keywords: Artemether and Lumefantrine, RP-HPLC, Validation.