目的:建立HPLC-ELSD测定复方苦参注射液中聚山梨酯80含量的方法,并与分光光度法测定结果进行比较。方法:采用TSKgel G2000SWXL色谱柱(7.8 mm×300 mm,5μm)及保护柱,流动相20 mmol·L-1醋酸铵-乙睛(88∶12),流速0.6 mL·min-1,柱温30℃;ELSD检测条件:蒸发器温度80℃,雾化器温度60℃,氮气流速2 L·min-1,进样体积10μL。结果:聚山梨酯80在13.11~52.42μg呈良好的线性关系(r=0.999 2),平均回收率为100.9%,RSD2.2%;与复方苦参注射液中聚山梨酯80理论投料量进行比较,UV法测得结果偏高,HPLC-ELSD法测定结果更接近理论值。结论:该法操作简便,重复性好,结果准确可靠,可用于聚山梨酯80含量控制。 OBJECTIVE: To establish a HPLC-ELSD method for the determination of polysorbate 80 in Compound Kushen Injection and compare the results with spectrophotometry. Methods: TSKgel G2000SWXL column (7.8 mm × 300 mm, 5 μm) and guard column were used. The mobile phase consisted of 20 mmol·L -1 ammonium acetate and acetonitrile (88:12), the flow rate was 0.6 mL · min- ℃; ELSD detection conditions: evaporator temperature 80 ℃, atomizer temperature 60 ℃, nitrogen flow rate 2 L · min-1, injection volume 10μL. Results: Polysorbate 80 showed a good linearity (r = 0.999 2) at 13.11-52.22 μg with an average recovery of 100.9% and a RSD of 2.2%. Compared with the theoretical dose of polysorbate 80 in Compound Kushen Injection The results of UV-spectrometry were higher than those of HPLC-ELSD. Conclusion: The method is simple, reproducible, accurate and reliable, and can be used to control polysorbate 80 content.