气相色谱法测定利福霉素钠注射液中丙二醇的含量

目的: 建立气相色谱法测定利福霉素钠注射液中丙二醇的含量。 方法: 采用毛细管色谱柱DB-FFAP,进样口温度为230℃,检测器温度为250℃,程序升温,初始温度80℃维持3 min,以10℃·min^-1的升温速率升至230℃,维持3 min,进样量为1 μL。 结果: 丙二醇在0.02%~0.15%(v/v)的范围内线性关系良好(r=0.999)。2个厂家样品的平均回收率分别为98.8%~99.7%、97.4%~104.3%(n=3)。 结论: 所建立的方法准确、简便、重复性好,可用于测定注射液中丙二醇的含量,更有效地控制药品质量。

Objective: To establish a GC method for the determination of propylene glycol in rifamycin sodium injection. Methods: The GC method was conducted on a DB-FFAP capillary column. The injector and detector were operated at 230℃ and 250℃,respectively. The temperature program consisted of an initial temperature of 80℃ held for 3 min,rose to 230℃ at a rate of 10℃·min^-1 and held for 3 min. The injection volume was 1 μL. Results: The calibration curve was linear in the range of 0.02%-0.15% (v/v) and the correlation coefficient was 0.999. The average recoveries of two kinds of samples from two different manufacturers were 98.8%-99.7% and 97.4%-104.3%(n=3),respectively. Conclusion: The established method is accurate,simple and reproducible. It is suitable to determinate propylene glycol in rifamycin sodium injection and can be effectively used for quality control of the drug.

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