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

J Pharm Biomed Anal. 2007 Sep 21;45(1):149-153. doi: 10.1016/j.jpba.2007.04.030. Epub 2007 Apr 29.

Abstract

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.

Publication types

  • Research Support, Non-U.S. Gov't
  • Validation Study

MeSH terms

  • Antimalarials / analysis*
  • Artemisinins / analysis*
  • Artesunate
  • Calibration
  • Chemistry, Pharmaceutical / methods*
  • Chromatography, Liquid
  • Mass Spectrometry
  • Pharmaceutical Preparations / analysis*
  • Pharmaceutical Preparations / standards
  • Quality Control
  • Reference Standards
  • Reproducibility of Results
  • Sesquiterpenes / analysis*

Substances

  • Antimalarials
  • Artemisinins
  • Pharmaceutical Preparations
  • Sesquiterpenes
  • Artesunate