GC法测定复方苦参注射液中聚山梨酯80的含量

目的: 建立测定复方苦参注射液中聚山梨酯80含量的气相色谱方法。 方法: 采用脂肪酸甲酯化法进行样品前处理。气相色谱条件:DB-WAX毛细管柱(PEG-20000,30 m×0.32 m×0.25 m);氢火焰离子化检测器(FID);进样口温度250 ℃,检测器温度为250 ℃;柱温初始温度为80 ℃,以10 ℃·min^-1升温至220 ℃,保持20 min;载气为氮气,恒定流速1 mL·min^-1,进样方式为分流进样,分流比10∶ 1;进样量为1 μL。 结果: 聚山梨酯80的进样浓度在0.1~5.0 mg·mL^-1(r=0.9998)范围内呈良好线性关系;平均回收率(n=3)为97.4%~100.7%。 结论: 该方法简便快速,可用于复方苦参注射液中聚山梨酯80的含量测定。

Objective: To establish a GC method for determination of polysorbate 80 in compound kushen injection. Methods: The gas chromatographic analysis was performed using Capillary column DB-WAX (PEG-20000,30 m×0.32 m×0.25 m).The detector was FID.Inlet temperature was 250 ℃ and the detector temperature was 250 ℃.Program temperature was used with initial column temperature of 80 ℃,and increasing to 220 ℃ at the rate of 10 ℃·min^-1,holding for 20 min.highly pure N₂ was adopted as carrier gas at the flow rate of 1 mL·min^-1.Split injection with split ratio of 10∶ 1.Injection volume was 1 μL. Results: The linear range for polysorbate 80 was 0.1-5.0 mg·mL^-1(r=0.9998);The average recoveries(n=3) were 97.37%-100.70%. Conclusion: This method is simple,quick and specific.It can be applied for determination of polysorbate 80 in compound kushen injection.