气相色谱法测定清开灵注射液中甘油的含量

GC Determination of Glycerol in Qing-Kai-Ling Injection

目的:建立清开灵注射液中甘油的含量测定方法,以监控清开灵注射液的质量。方法:采用气相色谱(GC)法,检测器为FID,检测器温度:250℃;色谱柱为石英毛细管柱(0.32 mm×30 m,1.8μm,Agilent DB-624);进样口温度为200℃;柱温:起始温度140℃,保持10 min;以50℃/min速率升温到220℃后,维持5 min,再以50℃/min速率升温到240℃后,维持8 min,载气为N2。结果:甘油对照品在0.2486-2.4855 mg/mL的浓度范围内,浓度与峰面积的线性关系良好;平均加样回收结果为99.8%,RSD%为0.4%。结论:该方法操作简便,灵敏度高,准确性好,可用于清开灵注射液中甘油的含量测定。

Objective： To evaluate the quality of Qing-Kai-Ling Injection,according to determining the contents of Glycerol. Methods： The gas chromatograph was equipped with a flame-ionization detector, maintained at about 250℃, and a quartz capillary column （0.32 mmx30 m, bonded with a 1.8 um layer of phase, Agilent DB-624）. The injection port temperature is maintained at 200℃. The column temperature is maintained at 140℃ for 10 minutes after injection, then programmed increase to 220 ~C at the rate of 50 per minute, and to maintain this temperature for 5 minutes,then at the rate of 50 per minute to 240℃ and to maintain this temperature for 8 minutes. The carrier gas is Nitrogen. Results： The standard curve of Glycerol showed good linearity over the range of 0.2486-2.4855 mg/mL respectively. The average recovery of the method was 99.$% with RSD%=0.4%. Conclusion： The method is simple, sensitive and accurate for the determination of Glycerol in QingKai-Ling Injection.