Validated RP-UPLC-PDA Method for simultaneous Estimation of Artemether and Lumefantrine in API and Tablet dosage form

Abstract

A specific, precise, accurate and robust isocratic RP-UPLC-PDA assay method was developed and validated for determination of Artemether and Lumefantrine in API and tablet dosage form. Isocratic separation was achieved on an Acquity UPLC BEH C18 column (50mm, 2.1mm, and 1.7µm) using mobile phase of Acetonitrile: 20mM Hexane sulfonic acid sodium salt adjust pH 2.5±0.05 with Ortho phosphoric acid (70:30% V/V) at a flow rate of 0.3ml/min, Temperature 40℃. The injection volume was 5µl and the detection was carried out at 218nm by using photo-diode array detector. Retention time of Artemether and Lumefantrine were found to be 0.908 min and 1.916min. The calibration plots were over the concentration range of 80-240μg/ml and 480-1440µg/ml for Artemether and Lumefantrine with correlation coefficient 0.999 and 0.999 respectively. The accuracywasobtained between 98.8% - 100.56% and 98.15% - 101.51% for Artemether and Lumefantrine respectively. The short retention time allows the analysis of a large number of samples in a short period of time andtherefore, will be cost-effective for routine analysis in the pharmaceutical industry.