毛细管气相色谱法测定聚桂醇原料中乙二醇、月桂醇、二甘醇的含量

目的: 建立聚桂醇原料药中3个有关物质乙二醇、月桂醇和二甘醇的毛细管气相色谱测定方法。方法: 采用DB-WAX(30 m×0.32 mm×0.25 μm)毛细柱,氢火焰离子检测器(FID),进样口温度230 ℃,检测器温度250 ℃,程序升温(起始温度180 ℃,维持7 min,以15 ℃·min^-1的速率升温至230 ℃,维持40 min)。结果: 在选定的色谱条件下,3个物质分离良好。乙二醇的回归方程为Y=846.8X-1.830(r=0.9993),线性范围为0.004～0.2 mg·mL^-1,平均回收率为100.0%(n=9);月桂醇的回归方程为Y=2.694×10³X-121.8(r=0.9992),线性范围为0.08～4.0 mg·mL^-1,平均回收率为100.7%(n=9);二甘醇的回归方程为Y=1.018×10³X-3.010(r=0.9992),线性范围为0.004～0.2 mg·mL^-1,平均回收率为99.6%(n=9)。结论: 本方法能用于聚桂醇原料的质量检测。

Objective: To establish a capillary GC method for the determination of ethylene glycol, lauryl alcohol and diethylene glycol in lauromacrogol. Methods: A DB-WAX column (30 m×0.32 mm×0.25 μm) was adopted.The inlet temperature was controlled at 230 ℃ and the FID detector temperature was 250 ℃.The oven temperature was initially held at 180 ℃ for 7 min and was then programmed to 230 ℃ at 15 ℃·min^-1 and held for another 40 min. Results: A good resolution was obtained between the peaks of ethylene glycol, lauryl alcohol and diethylene glycol.The linearity equation of ethylene glycol was Y=846.8X-1.830(r=0.9993), the linear range was 0.004-0.2 mg·mL^-1, and the average recovery was 100.0%(n=9).The linearity equation of lauryl alcohol was Y=2.694×10³X-121.8(r=0.9992), the linear range was 0.08-4.0 mg·mL^-1, and the average recovery was 100.7%(n=9).The linearity equation of diethylene glycol was Y=1.018×10³X-3.010(r=0.9992), the linear range was 0.004-0.2 mg·mL^-1, and the average recovery was 99.6%(n=9). Conclusion: The method can be operated for the lauromacrogol quality control.

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