VALIDATED REVERSE PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD FOR THE SIMULTANEOUS DETERMINATION OF ARTEMETHER AND LUMEFANTRINE IN FIXED COMBINED DOSAGE FORM

摘要

Objective: The present aim is to develop simple, precise, and accurate reverse phase high performance liquid chromatographic method (RP-HPLC) for the simultaneous assay of artemether and lumefantrine in fixed combined dosage form. Methods: The chromatographic study was carried out on Hypersil C18 column (250×4.6 mm, 5 μ) with mobile phase containing a mixture of KH2PO4 buffer (pH-3.5) and acetonitrile in the ratio of 45:55% v/v at a flow rate of 1.0 ml/minute with ultraviolet detection at 218 nm in ambient column temperature. Results: Using the optimized chromatographic conditions artemether and lumefantrine eluted with retention times of 2.207 and 3.733 minutes, respectively. The method was validated according to ICH guidelines with good reproducibility and linear responses, y=60.813.x+629.53 (r2=0.9982) for artemether and y=88.3108.x+2370.2 (r2=0.9912). The % relative standard deviations of intra-day precision was ranged 0.378% and 1.26% for artemether and 0.459% and 1.15% for lumefantrine, respectively. The percentage recoveries were ranged from 99.96% to 100.02% for artemether and 99.96-99.97% for lumefantrine, respectively. Conclusions: The developed RP-HPLC method was validated as per ICH guidelines and was found to be best suitable for pharmacokinetic studies of these mentioned drugs. Keywords: Artemether, Lumefantrine, ICH guidelines.