Novel Stability Indicating Validated RP-HPLC Method for Simultaneous Quantification of Artemether and Lumefantrine in Bulk and Tablet
Prasenjit Mondal, S. Shobha Rani and R. RamakrishnaAffiliation:
Department of Pharmaceutical analysis, Vaageswari college of Pharmacy, Karimnagar, Andhra Pradesh, India, 505481.
AbstractThe 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 mobile phase with waters symmetry Shield Rp18Column (250 mm x 4.6mm x 5) µm as stationary phase at flow rate of 1.0 mL/min. The detection was performed at 273 nm. The retention times for lumefantrine and artemether were found 2.249 and 4.516 min respectively. The proposed method showed good inra-day precisions (%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 limit were 1.615 µg/mL and 5.383 µg/mL for Artemether, 7.82 µg/mL and 26.07 µg/mL for lumefantrine. This method was found to have good percentage recovery in 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 showed good solution stability. This study reporting the stability indicating easiest method ever developed, useful for the routine analysis.
Artemether, lumefantrine, RP-HPLC, stability, validation, ICH
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