DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF ARTESUNATE AND MEFLOQUINE

Abstract

   A simple, precise, rapid and accurate reversed-phase high performance liquid chromatography (RP-HPLC) method for the simultaneous estimation of Artesunate and Mefloquine was developed and validated as per ICH Guidelines. Chromatography was carried out by isocratic technique on a Develosil C18 (4.6mm×150mm, 5µm) Column with mobile phase mixture of Acetonitrile: Phosphate buffer pH-5.2 (25:75v/v) was used as a mobile phase and the pH was adjusted into 5.2 by using with ortho-phosphoric acid, at a flow rate of 1.0 ml/min. The UV range was detected at 248 nm for Artesunate and Mefloquine respectively. The different analytical performance parameters such as linearity, precision, accuracy, and specificity, limit of detection (LOD) and limit of quantification (LOQ) were determined according to International Conference on Harmonization ICH Q2B guidelines. The linearity of the calibration curves for each analyte in the desired concentration range is good (r2 >0.9). The recovery of the method was between 99.95% and 100.10% for Artesunate and Mefloquine respectively. Hence the proposed method is highly sensitive, precise and accurate and it successfully applied for the reliable quantification of API content in the commercial formulations of Artesunate and Mefloquine.