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 3.0 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.
Lindegårdh
N
N
Faculty of Tropical Medicine, Mahidol University, Bangkok 10400, Thailand; Nuffield Department of Clinical Medicine, Centre for Tropical Medicine, University of Oxford, Oxford, UK. Electronic address: niklas@tropmedres.ac.
Dondorp
A M
AM
Faculty of Tropical Medicine, Mahidol University, Bangkok 10400, Thailand; Nuffield Department of Clinical Medicine, Centre for Tropical Medicine, University of Oxford, Oxford, UK.
Singhasivanon
P
P
Faculty of Tropical Medicine, Mahidol University, Bangkok 10400, Thailand.
White
N J
NJ
Faculty of Tropical Medicine, Mahidol University, Bangkok 10400, Thailand; Nuffield Department of Clinical Medicine, Centre for Tropical Medicine, University of Oxford, Oxford, UK.
Day
N P J
NPJ
Faculty of Tropical Medicine, Mahidol University, Bangkok 10400, Thailand; Nuffield Department of Clinical Medicine, Centre for Tropical Medicine, University of Oxford, Oxford, UK.
D000962:Antimalarials / Q000032:analysis*; D037621:Artemisinins / Q000032:analysis*; D000077332:Artesunate; D002138:Calibration; D002626:Chemistry, Pharmaceutical / Q000379:methods*; D002853:Chromatography, Liquid; D013058:Mass Spectrometry; D004364:Pharmaceutical Preparations / Q000032:analysis* / Q000592:standards; D011786:Quality Control; D012015:Reference Standards; D015203:Reproducibility of Results; D012717:Sesquiterpenes / Q000032:analysis*
D000962:Antimalarials; D037621:Artemisinins; D004364:Pharmaceutical Preparations; D012717:Sesquiterpenes; D000077332:Artesunate