Analytical Method Development and Validation for Estimation of Lumifantrine in Pharmaceutical Dosage Forms by HPLC

A Simple, rapid, sensitive, precise, accurate, stability indicating and reproducible of High Performance Liquid chromatography (HPLC) method has been developed for the estimation of Lumifantrine in pharmaceutical Tablet dosage forms. The HPLC method was carried out using Waters Symmetry C18 (250 X 4.5 mm) analytical column with maintained the column oven temperature 35 °C and isocratic pump mode. The mobile phase compressing of water, acetonitrile and glacial acetic acid in the ratio of 48: 52: 1, v/v/v with delivered the flow rate of 1.2mL /min and the detected the lumifantrine at 276 nm from PDA detector. The retention time of lumifantrine was 4.65 minutes. This method has been validated as per ICH guidelines and the validation data showed that the assay is sensitive, specific and reproducible for the determination of lumifantrine in the dosage form. The method is linear from 10μgmL -1 to 100μgmL -1 and linear correlation coefficient (R 2 ) was more than 0.9990. The accuracy of the method by recovery was found between 99.44 and 100.14 %. Mean inter and intraday assay relative standard deviation (RSD) were less than 1.0%. The proposed method