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HPLC study of related substances in artemether and Lumefantrine tablets

Manisha U.Phadke, Vivek K.Jadhav, Rajendra K.Jadhav, Yatish K.Bansal, Dattatray Patil, Shraddha Pawar,Pranita Padwal

A simple, sensitive reverse phase liquid chromatographic method involving flow gradient and wave length gradient has been developed for detection and quantitative determination of related compounds namely dihydroartemisinin, alpha artemether, artemisinin, impurityA, PCB andDBA inArtemether and Lumefantrine tablets, used as an antimalarial fixed dose combination. Efficient chromatographic separation was achieved on 250  4.6mm, 5mparticle size,Water SymmetryC18 column,withmobile phase combination containing buffer with decane sulphonic acid sodium salt, sodium dihydrogen phosphate monohydrate and triethylamine in 1000ml water. Adjust the pH to 2.3 with Orthophosphoric Acid. and acetonitrile delivered in gradient mode and quantification carried out at wavelength 210nm and 380 nm at the flow rate of 1.0 mL min-1 upto 25 mins and then increased to 2.0 mL min- upto 50 mins. The chromatographic conditions were optimized to avoid interferences fromthe excipients aswell to achieve acceptable resolution between dihydroartemisinin, imput\rity A and and artemether and also well between PCB and DBA and Lumefantrine. The developedmethod, validated according to the ICH Q2R guidelines, met the pharmaceutical analysis requirements and can be successfully applied for intended purpose to establish the product quality.