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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。
A method for the determination of related substances in benzyl alcohol injection by gas chromatography was established. The system was heated on a Phenomenex ZB-WAX (30 m × 0.32 mm × 0.5 μm) capillary column with an initial temperature of 50 ° C for 15 min and a ramp of 5 ° C / min to 220 ° C for 35 min. ; Carrier gas: constant flow nitrogen; inlet temperature 200 ° C; FID detector temperature 310 ° C. Gas chromatographic determination of benzyl alcohol injection of impurities and the main components can be completely separated, the minimum detection of 1.4 ng. Conclusion: The method is simple, accurate and reliable, and the separation of related substances is good. It can be used for the quality control of benzyl alcohol injection.