RP-HPLC Method Development And Validation For Simultaneous Estimation of Artemether and Lumefantrine in Pharmaceutical Dosage Form
Ganesh Mali*, Vilas Arsul*, Anup Puranpole, Yogesh Nalte
The importance of Antimalarial drugs are increasing day by day & used for method development by reverse phase HPLC. In literature survey few analytical methods have been reported for determination of drug out of which some are time consuming and costly. So this research work is dedicated to develop simple, efficient, Economical, fast, reliable and new method for estimation of Selected drug. RP-HPLC analysis was performed on the Grace C-18 (250 mm × 4.6 mm), 5 μm particle size and using Acetonitrile: Potassium Phosphate buffer (60:40v/v) as mobile phase; flow rate was adjusted to 1 ml/min. The detection was carried out at 215 nm. The average retention times of Artemether and Lumefantrine was observed 8.11 min and 10.25 min at 215 nm wavelength respectively. Linearity was observed in the concentration ranges of 2–10μg/ml (r2 = 0.999) for ART and 12 - 60 μg/ml (r2 = 0.999) for LUME. The method has been successively applied for the determination of ARTEMETHER and LUMAFANTRINE in tablet formulation. There was no interference from the excipients commonly present in the tablet. Accuracy of the method was studied by the recovery studies at three different levels 80 %, 100 % and 120 % level. The % recovery was found to be within the limits of the acceptance criteria with average recovery of 97-105%. The method was found to be accurate, precise and specific for estimation of Artemether and Lumefantrine drugs in pharmaceutical dosage forms.
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