毛细管气相色谱法测定注射用地西他滨中的残留溶剂
发布时间:2018-02-02 19:57
本文关键词: 注射用地西他滨 残留溶剂 毛细管气相色谱法 出处:《中国药房》2015年33期 论文类型:期刊论文
【摘要】:目的:建立测定注射用地西他滨中残留溶剂的方法。方法:采用毛细管气相色谱法,按内标法计算残留溶剂的含量。色谱柱为Agilent DB-624毛细管柱,检测器为氢火焰离子化检测器,检测器温度为280℃,进样口温度为230℃,柱温采用程序升温,载气为高纯氮,流速为1.5 ml/min,分流比为50∶1,进样方式为直接进样,进样量为1μl。结果:乙醇、乙醚、异丙醇、乙腈、二氯甲烷、四氢呋喃、环己烷、甲苯、N,N-二甲基甲酰胺的检测质量浓度线性范围分别为0.100 3~2.507、0.101 3~2.532、0.102 2~2.556、0.008 3~0.207 8、0.012 4~0.309 3、0.014 8~0.369 4、0.078 1~1.953、0.024 9~1.250、0.017 6~0.440 9 mg/ml(r均≥0.999 2);精密度、重复性试验的RSD2%;加样回收率为96.70%~101.60%,RSD为0.59%~1.82%(n=9)。结论:该方法简便、准确、重复性好,适用于注射用地西他滨中残留溶剂的测定。
[Abstract]:Objective: to establish a method for the determination of residual solvents in descitabine injection. Methods: capillary gas chromatography was used. The content of residual solvent was calculated by internal standard method. The chromatographic column was Agilent DB-624 capillary column, the detector was hydrogen flame ionization detector, and the detector temperature was 280 鈩,
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