摘要
目的 建立阿立哌唑原料药中残留有机溶剂乙醇、乙腈、二氯甲烷、N,N-二甲基甲酰胺的气相色谱测定方法。方法 采用AC-1毛细管色谱柱（30m×0.53mm×1.0μm）;氮气为载气;初始柱温为40℃,保持3min后以40℃/min的速率升至160℃,保持2min;氢火焰离子化检测器温度为200℃;进样口温度为160℃;进样量为1μL。结果 阿立哌唑原料药中的4种有机溶剂完全分离,在所考察的浓度范围内均具有良好的线性关系,加样回收率在98.1%~99.0%范围内。3批阿立哌唑样品中均未检出4种有机溶剂。结论 该方法准确、灵敏度高,适用于阿立哌唑原料药中有机溶剂残留量的测定。
OBJECTIVE To establish a gas chromatography method for the residual organic solvents determination of ethanol, acetonitrile, dichloromethane and N, N-dimethyl-Formamide in aripiprazole raw material drug. METHODS A AC-1 capillary chromatography column （ 30m × 0. 53mm × 1.0μm） was used, nitrogen was used as carrier gas and the inject volumn was 1 μL, the temperature of flame ionization detector and the injector were controlled at 200℃ and 160℃ respectively. After controlled at 40℃ for threeminutes, the temperature of chromatography column was rised to 160℃ with a speed of 40℃/min and maintain twominutes. RESULTS The four organic solvents were separated completely and had good linear relation within the investigated concerntration, the mean recovery rates all within the range of 98. 1% -99. 0%. the four kinds of residual organic solvents didn＇t test in three batch of Aripiprazole sample. CONCLUSION The method is accurate and sensitive,which can be used for the determination of residual organic solvents in aripiprazole.
出处
《海峡药学》
2016年第11期68-70,共3页
Strait Pharmaceutical Journal
关键词
阿立哌唑
气相色谱法
有机溶剂残留量
Aripiprazole
Gas chromatography
Residual organic solvents
