A new RP-HPLC method development and validation for Simultaneous estimation of lumefantrine & artemether using bulk and Pharmaceutical Dosage Forms

Rajkiran Kolakota*, G. Sai Krishna
Department of Pharmaceutical Analysis, Sri Sivani College of Pharmacy, NH-16, Chilakapalem Jn, Srikakulam-532402, A.P.

A B S T R A C T
A simple, rapid, accurate and precise isocratic reversed phase high performance liquid chromatographic method has been developed and validated for Simultaneous Estimation of Lumefantrine and Artemether in Combined Dosage Form. The chromatographic separation was carried out on Kromosil column (250×4.6mm× 5µ) with a mixture of Phosphate buffer (KH₂PO₄): Methanol (30:70, v/v) as a mobile phase at a flow rate of 1.0mL/min. PDA detection was performed at 238 nm. The retention times were 3.800 minutes and 2.343 minutes for Lumefantrine and Artemether respectively. Calibration plots were linear (r²=0.999 for both Lumefantrine and Artemether respectively) over the concentration range of 72-168µg/mL for Lumefantrine and 16-24 µg/mL for Artemether. The method was validated for linearity, precision, accuracy, ruggedness and robustness. The proposed method was successfully used for simultaneous estimation of Lumefantrine and Artemether in combined dosage form. Validation studies revealed that the proposed method is specific, rapid, reliable and reproducible. The high % recovery and low % RSD confirms the suitability of the proposed method for routine quality control analysis of Lumefantrine and Artemether in bulk and tablet dosage forms.
Keywords: Lumefantrine, Artemether, Estimation, HPLC