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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1μL。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 gas chromatographic method for the determination of polysorbate 80 in compound Kushen injection. Methods: The fatty acid methyl esterification method for sample preparation. Gas chromatographic conditions: DB-WAX capillary column (PEG-20000, 30 m × 0.32 m × 0.25 m); flame ionization detector (FID); inlet temperature of 250 ℃, detector temperature of 250 ℃; The initial temperature was 80 ° C, and the temperature was raised to 220 ° C at 10 ° C .min-1 for 20 min. The carrier gas was nitrogen at a constant flow rate of 1 mL.min-1. The injection mode was split injection with split ratio of 10: 1. Injection volume of 1μL. Results: The linearity of polysorbate 80 was linear in the range of 0.1-5.0 mg.mL-1 (r = 0.9998). The average recoveries (n = 3) ranged from 97.4% to 100.7%. Conclusion: This method is simple and rapid and can be used for the determination of polysorbate 80 in Compound Kushen Injection.