Validation and application of a liquid chromatographic–mass spectrometric method for determination of artesunate in pharmaceutical samples

A simple and rapid liquid chromatographic–mass spectrometric assay for the evaluation of artesunate in vials for injection has been developed and validated. The content of each vial was dissolved in 3.0mL of methanol using a SGE analytical syringe (1.0mL). Each sample was diluted to a theoretical concentration of 1000ng/mL and analysed in triplicate. Three replicates of calibration standards at concentrations 500, 1000 and 1500ng/mL were used to construct a calibration curve. Artesunate was analysed by liquid chromatography with atmospheric pressure chemical ionisation (APCI) mass spectrometric (MS) detection on a Hypersil Gold column (100mm×4.6mm) using a mobile phase containing methanol–ammonium acetate 10mM pH 5.3 (70:30, v/v) at a flow rate of 1mL/min. The assay was implemented for the analysis of artesunate for injection purchased from Guilin Pharmaceutical Company in China.