一种用于测定药物样品中青蒿琥酯的液相色谱-质谱法的验证与应用
Validation and application of a liquid chromatographic-mass spectrometric method for determination of artesunate in pharmaceutical samples.
作者信息
Lindegårdh N, Dondorp A M, Singhasivanon P, White N J, Day N P J
机构信息
Faculty of Tropical Medicine, Mahidol University, Bangkok 10400, Thailand; Nuffield Department of Clinical Medicine, Centre for Tropical Medicine, University of Oxford, Oxford, UK.
Faculty of Tropical Medicine, Mahidol University, Bangkok 10400, Thailand; Nuffield Department of Clinical Medicine, Centre for Tropical Medicine, University of Oxford, Oxford, UK.
出版信息
J Pharm Biomed Anal. 2007 Sep 21;45(1):149-153. doi: 10.1016/j.jpba.2007.04.030. Epub 2007 Apr 29.
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.
已开发并验证了一种用于评估注射用青蒿琥酯小瓶中药物含量的简单快速的液相色谱 - 质谱分析法。使用SGE分析注射器（1.0 mL）将每个小瓶中的内容物溶解于3.0 mL甲醇中。将每个样品稀释至理论浓度1000 ng/mL，并进行三次重复分析。使用浓度为500、1000和1500 ng/mL的校准标准品的三个重复样品构建校准曲线。在Hypersil Gold柱（100 mm×4.6 mm）上，采用含有甲醇 - 10 mM pH 5.3乙酸铵（70:30，v/v）的流动相，流速为1 mL/min，通过液相色谱 - 大气压化学电离（APCI）质谱（MS）检测对青蒿琥酯进行分析。该分析方法用于对从中国桂林制药公司购买的注射用青蒿琥酯进行分析。
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