Abstract
The present paper reports the development of novel, stable & validated RP HPLC method for the simultaneous estimation of Artemether (ART) and lumefantrine (LUM) in bulk and tablet dosage form. Good chromatographic separation was achieved by isocratic mode with a mixture of phosphate buffer: methanol in the ratio of 50: 50 as the mobile phase with waters symmetry Shield Rp18Column (250 mm x 4.6mm x 5) μm as stationary phase at a flow rate of 1.0 ml/min. The detection was performed at 273 nm. Retention time for LUM and ART were found 2.249 and 4.516 min respectively. The proposed method showed good intra-day precision (%RSD=0.068for ART, 0.033 for LUM), good accuracy (recovery for both ART and LUM >99% ), and high correlation coefficient(R2= 0.999 both ATM and LUM). The detection and quantitation limits were 0.55 μg/ml and 1.35 μg/ml for ART and 0.09 μg/ml and 0.32 μg/ml for LUM. This method found to have a good percentage recovery in a forced degradation study using acid, base, oxidation, photolytic, thermal and neutral conditions indicates well separation of both the drugs with other degradation products and the present method has shown good solution stability. Hence, the present study reports ever developed stability indicating easiest method which is useful for the routine analysis.
Keywords: Artemether, lumefantrine, RP-HPLC, stability, validation, ICH.
Graphical Abstract
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