| 张辉,王志华,解晓冬,黄保红,李明花,李建伟,乔玉峰.氢溴酸沃替西汀原料药中催化剂钯残留监测方法建立[J].中国药事,2017,(1):69-73 |
| 氢溴酸沃替西汀原料药中催化剂钯残留监测方法建立 |
| Establishment of a Method for Monitoring the Catalyst Palladium Residual Content in Vortioxetine Hydrobromide Bulk Drug |
| 投稿时间：2016-08-15 |
| DOI：10.16153/j.1002-7777.2016.11.013 |
| 中文关键词: 石墨炉原子吸收分光光度法 氢溴酸沃替西汀 钯 含量测定 催化剂 残留量 |
| 英文关键词: graphite furnace atomic absorption spectrometry vortioxetine hydrobromide palladium content determination catalyst residue |
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| 中文摘要: |
| 目的：建立氢溴酸沃替西汀原料药中催化剂钯的残留量测定方法。方法：采用石墨炉原子吸收分光光度法测定氢溴酸沃替西汀中钯的残留量。试验条件：光源为钯空心阴极灯，波长247.6 nm，狭缝0.4 nm，灯电流2 mA，石墨管为横向加热方式，石墨炉程序升温。结果：钯浓度在0~80 μg·L-1与吸光度呈良好的线性关系y=0.003x-0.001（r=0.9995），检测限为0.59 μg·L-1，定量限为1.96 μg·L-1；平均回收率为102.1%，RSD为3.24%（n=9）。结论：该方法经方法学验证，可用于氢溴酸沃替西汀原料药中钯含量的测定，可为该原料药质量标准的建立提供依据。 |
| 英文摘要: |
| Objective: To establish a method for the content determination of palladium catalyst residue in vortioxetine hydrobromide. Methods: Graphite furnace atomic absorption spectrometry method was used to determine the palladium residue content in vortioxetine hydrobromide. Test conditions were as follows:the palladium hollow cathode lamp was used as the light source, the detection wavelength was 247.6 nm, the slit was 0.4 nm, and the lamp current was 2 mA with transverse heating graphite tube. The programmed heating was used for graphite furnace. Results: It showed a good linear relationship within the concentration range of 0-80 μg·L-1 (r=0.9995). The detection limit and the characteristic concentration were 0.59 μg·L-1 and 1.96 μg·L-1, respectively. The average recovery was 102.1% with RSD of 3.24% (n=9). Conclusion: This method could be used for the determination of the trace palladium content in vortioxetine hydrobromide after methodology verification, and could provide references for the establishment of quality standard of raw material medicine. |
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