气相色谱法同时测定利福平注射液中的1,2-丙二醇、二甘醇和环氧丙烷

Determination of propylene glycol, diethylene glycol and propylene oxide in rifampicin injection by GC

目的建立气相色谱法测定利福平注射液中有机溶剂的含量。方法采用气相色谱法,使用SUPEL COWAX固定相毛细管柱;以高纯氮气为载气;以FID为检测器。结果 1,2-丙二醇在31.83~1273.0μg·m L^(-1)与峰面积呈良好的线性关系,r=0.9999(n=6);二甘醇在1.5~60μg·m L^(-1)与峰面积呈良好的线性关系,r=0.9994(n=6);环氧丙烷在1.5~60μg·m L^(-1)与峰面积呈良好的线性关系,r=0.9993(n=6)。平均回收率均在96.1%~99.6%。结论该方法准确可靠,可用于利福平注射液中1,2-丙二醇、二甘醇和环氧丙烷的检测。

Objective To develop a GC method to determine organic solvents in rifampicin injection. Methods A SUPEL COWAX capillary column was used. The carrier gas was nitrogen and the GC was equipped with hydrogen flame-ionizition detector. Results The analytes had a good linearity at 31.83- 1273.0 μg·m L^-1, r =0.9999（n = 6）（propylene glycol）; at 1.5- 60 μg·m L^-1, r = 0.9994（n = 6）（diethylene glycol）; and at 1.5-60 μg·m L^-1, r = 0.9993（n = 6）（propylene oxide）. The average recovery was at 96.1%- 99.6%. Conclusion The method is accurate and reliable, suitable for the determination of propylene glycol, diethylene glycol and propylene oxide in rifampicin injection.