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

Journal article

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.

Authors: Lindegårdh, N; Dondorp, A; Singhasivanon, P; White, N; Day, N

• Publication status: Published
• Journal: Journal of pharmaceutical and biomedical analysis
• Volume: 45
• Issue: 1
• Pages: 149-153
• Publication date: 2007-09-01
• DOI: 10.1016/j.jpba.2007.04.030
• EISSN: 1873-264X
• ISSN: 0731-7085
• Language: English
• Keywords: Chromatography, Liquid; Calibration; Reference Standards; Antimalarials; Pharmaceutical Preparations; Quality Control; Artemisinins; Reproducibility of Results; Chemistry, Pharmaceutical; Mass Spectrometry; Sesquiterpenes