目的 建立高效液相色谱法同时测定多索茶碱注射液中9种杂质的含量.方法 使用CAPCELL PAK C18 ME色谱柱(4.6 mm × 250 mm,5 μm);以乙腈-磷酸盐缓冲液为流动相,梯度洗脱,流速为1.0mL·min-1,柱温为30℃,检测波长为273 nm.对多索茶碱注射液中可能存在的9种杂质进行定量分析和限度检查.结果 在该条件下,9种杂质均能完全分离,回收率均在97.0％～105.0％.结论 该方法专属性强,重复性好,可用于多索茶碱注射液有关物质的测定.
Simultaneous determination of 9 impurities in doxofylline injection by HPLC
Objective To determine 9 impurities in doxofylline injection by high performance liquid chromatography(HPLC).Methods A CAPCELL PAK C18 ME column(4.6 mm×250 mm,5 μm)was used.Acetonitrile-phosphate buffered saline was used as the mobile phase,with gradient elution.The flow rate was 1.0 mL·min-1,the column temperature was 30 ℃,and the detection wavelength was 273 nm.Nine possible impurities in doxofylline injection were quantitatized and the limit was checked.Results Under these conditions,the 9 impurities were completely separated,with recoveries between 97.0％～105.0％.Conclusion This method is specific and reproducible,and can be used for the determination of related substances in doxofylline injection.
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