This document describes a validated analytical procedure, using High Performance Liquid Chromatography (HPLC) with Refractive Index (RI) detection, for the quantification of artemisinin from Artemisia annua. The first section constitutes a validated assay method suitable for transfer to analytical laboratories. Subsequent sections detail the experiments on specificity, linearity, range, accuracy, precision, detection and quantitation limits, robustness and system suitability which have been performed to validate the methodology. The assay was found to be acceptable under each criterion tested.
003-003a/1; 29 pp.