气相色谱法测定依托泊苷注射液中乙二醇与二甘醇的量

目的采用气相色谱（GC）法测定依托泊苷注射液中乙二醇与二甘醇的量。方法色谱柱为DB-WAXetr毛细管柱（30m×0.32mm,1.0μm）,采用程序升温方式。结果乙二醇检测质量浓度在1.60～667.8μg/mL范围内与峰面积线性关系良好,线性回归方程为Y=523.59X-2.8439（r=0.9998）,平均回收率为103.1%,RSD为1.9%（n=9）;二甘醇检测质量浓度在1.61～670.2μg/mL范围内与峰面积线性关系良好,线性回归方程为Y=567.48X-1.8425（r=0.9999）,平均回收率为99.8%,RSD为1.6%（n=9）。结论 GC法简单、灵敏,可用于依托泊苷注射液的质量控制。

Dertermination of Ethylene Glycol and Diethylene Glycol in Etoposide Injection by GC

Objective To establish a method for the determination of ethylene glycol and diethylene glycol in Etoposide Injection by GC. Methods The DB-WAXetr column （30 m×0.32 mm,1.0 μm） was used and the column temperature was programmed.Results Ethylene glycol had a good linear relation in the range of 1.60-667.8 μg/mL and the linear equation of ethylene glycol was Y=523.59X-2.843 9（r=0.999 8）.The average recovery rate was 103.1%and the RSD was 1.9%（n=9）.Diethylene glycol had a good linear relation in the range of 1.61-670.2 μg/mL and its linear equation was Y=567.48X-1.842 5（r=0.999 9）.The average recovery rate was 99.8%and the RSD was 1.6%（n=9）.Conclusion The method is simple and sensitive,which can be used to control the quality of Etoposide Injection.