Validation and application of a liquid chromatographic-mass spectrometric method for determination of artesunate in pharmaceutical samples
Validation and application of a liquid chromatographic-mass spectrometric method for determination of artesunate in pharmaceutical samples
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DOI：
10.1016/j.jpba.2007.04.030
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发表时间：
2007-09-21
影响因子：
3.4
通讯作者：
Day, N. P. J.
中科院分区：
文献类型：
--
作者：
Lindegardh, N.;Dondorp, A. M.;Day, N. P. J.
建立了一种简便、快速的测定注射用青蒿琥酯含量的高效液相色谱-质谱法，用SGE分析注射器(1.0mL)将每瓶中的青蒿琥酯溶于3.0mL甲醇中。每个样品被稀释到1000 ng/mL的理论浓度，并进行一式三份的分析。以浓度为500、1000和1500 ng/m L的三次重复标准建立校正曲线。青蒿琥酯在Hypersil Gold色谱柱(100圈×4.6 mm)上，流动相为甲醇-10 mM醋酸铵pH 5.3(70：30，v/v)，流速为1mL/min。本方法用于中国桂林药业公司生产的注射用青蒿琥酯的含量测定。(C)2007 Elsevier B.V.保留所有权利。
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 turn 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. (C) 2007 Elsevier B.V. All rights reserved.