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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 3.0 mL of methanol using a SGE analytical syringe (1.0 mL). Each sample was diluted to a theoretical concentration of 1000 ng/mL and analysed in triplicate. Three replicates of calibration standards at concentrations 500, 1000 and 1500 ng/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 (100 mm x 4.6 mm) using a mobile phase containing methanol-ammonium acetate 10 mM pH 5.3 (70:30, v/v) at a flow rate of 1 mL/min. The assay was implemented for the analysis of artesunate for injection purchased from Guilin Pharmaceutical Company in China.

Original publication

DOI

10.1016/j.jpba.2007.04.030

Type

Journal article

Journal

J Pharm Biomed Anal

Publication Date

21/09/2007

Volume

45

Pages

149 - 153

Keywords

Antimalarials, Artemisinins, Artesunate, Calibration, Chemistry, Pharmaceutical, Chromatography, Liquid, Mass Spectrometry, Pharmaceutical Preparations, Quality Control, Reference Standards, Reproducibility of Results, Sesquiterpenes