高效液相色谱-蒸发光散射法测定冠心宁注射液中聚山梨酯80的含量

Determination of polysorbate 80 in Guanxinning injection by HPLC-ELSD

目的:采用高效液相色谱-蒸发光散射法,建立冠心宁注射液中聚山梨酯80的含量测定方法。方法:采用TSK GELG2000SWxl色谱柱(7.8 mm×300 mm,5μm),以乙腈-20 mmol·L-1醋酸铵溶液(10∶90)为流动相,流速0.6 mL·min-1,柱温30℃,蒸发光检测器检测,漂移管温度103℃,载气为氮气,流量为2.3 L·min-1。结果:聚山梨酯80进样量在5.13～51.30μg范围内线性关系良好(r=0.9977);方法回收率为98.03%(RSD=1.6%,n=6)。结论:该方法简单、快速,重复性好,可作为冠心宁注射液中聚山梨酯80的质量控制方法,为降低临床不良反应的发生提供技术保障。

Objective：To establish the method for determination of polysorbate 80 in Guanxinning injection by HPLC-ELSD.Methods： It was performed by HPLC-ELSD with TSK GEL G2000SWxl（7.8 mm×300 mm,5 μm） column.Acetonitrile and 20mmol·L-1 ammonium acetate（10∶90） was used as mobile phase,the flow rate was 0.6 mL·min-1,and the temperature was set at 30 ℃.The evaporated light scattering detector was adopted.The drift tube temperature was 103 ℃,and the gas flow rate was 2.3 L·min-1.Results： The calibration curve showed good linearity of polysorbate 80 in the test range from 5.13 to 51.30 μg（r=0.9977）;The method recovery（n=6） was 98.03% with RSD of 1.6%.Conclusion： The method is simple,rapid,accurate and reliable,and it can be applied to control the quality of polysorbate 80 in Guanxinning injection.Also,it can ensure the safety of clinical use.