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气相色谱法测定苯甲醇注射液的有关物质
GC Determination of Related Substances of Benzyl Alcohol Injection
【摘要】 建立应用气相色谱法测定苯甲醇注射液有关物质的方法。采用Phenomenex ZB-WAX(30 m×0.32 mm×0.5μm)毛细管色谱柱,程序升温(初始温度为50℃,保持15 min,再以5℃/min的升温速率升至220℃,保持35 min);载气:恒流氮气;进样口温度200℃;FID检测器温度310℃。气相色谱法测定苯甲醇注射液中杂质与主成分能够完全分离,最低检测量为1.4 ng。结论:该方法简单、精确、可靠,有关物质的分离度较好,可用于苯甲醇注射液质量控制。
【Abstract】 To establish a GC method for determination of the content of Benzyl alcohol injection,using Phenomenex ZB-WAX( 30 m× 0. 32 mm × 0. 5 μm) capillary column,programmed temperature( the initial temperature is 50 ℃ and maintain this temperature for15 minutes,then the temperature increased to 220 ℃ at rate of 5 ℃ / min,maintain this temperature for 35 minutes); nitrogen as carrier gas; the temperature of injection port is 200 ℃; the temperature of FID detection is 310 ℃. Results showed that the GC method for the determination of the content of Benzyl alcohol injection was good in determining related substances and the main components can be completely separated and the limit of detection is 1. 4 ng. This method is easy to operate,accurate,reliable,and the related substances have good separating degree,so the method can be used to control the quality of Benzyl alcohol injection.
【Key words】 Benzyl alcohol injection; GC; Related substance; Benzaldehyde; Benzoic acid; Benzyl ether;
- 【文献出处】 药物生物技术 ,Pharmaceutical Biotechnology , 编辑部邮箱 ,2016年03期
- 【分类号】R927.2;O657.71
- 【被引频次】2
- 【下载频次】169