A New Stability Indicating RP-HPLC Method for Simultaneous Determination of ARTEMETHER And Lumifantrine in its Bulk and Pharmaceutical Dosage Forms

The chromatographic conditions were successfully developed for the separation of by artemether and lumifantrine using  symmetry C18 column (4.6×150mm) 5µ,  A wavelength of 290 nm was selected and the mobile phase consists of triehtylamine  buffer (PH 6 adjusted with ortho phosphoric acid) and methanol in 20:80 % v/v ratios at a flow rate of 0.8 ml/min were found to be optimum conditions for analysis. The peaks were well resolved with symmetry C18 column. System suitability studies were also carried out which includes theoretical plates, resolution and tailing factors etc. The accuracy studies were shown as % recovery for Artemether and Lumefantrine at 50 %, 100 % and 150 %. The limits of % recovered should be in the range of 98-102 %. The results obtained for Artemether and Lumefantrine were found to be within the limits. Hence the method was found to be accurate. The accuracy studies showing % recovery of Artemether were found to be 99.9 %, 99 % and 99.9. % respectively and the % recovery of Lumefantrine were found to be 99.9%, 99.9 % and 98.9 % respectively. In the System precision study, the % RSD was found to be less than 2 %. For Artemether 1.7 and Lumefantrine 1.2 which indicates that the system has good reproducibility. For ID precision studies six replicate injections of Artemether and Lumefantrine were performed. The % RSD was determined for peak areas of Artemether and Lumefantrine. The acceptance limit should not be more than 2 % and the results were found to be within the acceptance limits. Using the optimized chromatographic conditions, chromatograms of mixed standard solutions which contained Artemether and Lumefantrine were recorded. Retention times of Artemether and Lumefantrine were found to be 2.9 min and 4.6 min respectively. Calibration curves were obtained by using peak area vs. concentration. Artemether and Lumefantrine show linearity in the range of 0.1 – 0.5 µg/ml and 0.6 – 3.0 µ/ml. Calibration curve was plotted and correlation co-efficient for both the drugs Artemether and Lumefantrine were found to be 0.999 and 0.999 respectively