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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 a method for the determination of polysorbate 80 in Guanxinning injection by high performance liquid chromatography-evaporative light scattering. Methods: TSK GELG2000SWxl column (7.8 mm × 300 mm, 5 μm) was used with a mobile phase of acetonitrile-20 mmol·L-1 ammonium acetate (10:90) at a flow rate of 0.6 mL · min- , Evaporative light detector detection, drift tube temperature 103 ℃, carrier gas nitrogen, flow rate 2.3 L · min-1. Results: The linear range of polysorbate 80 was 5.13 ~ 51.30μg (r = 0.9977). The recovery rate was 98.03% (RSD = 1.6%, n = 6). Conclusion: The method is simple, rapid and reproducible. It can be used as a quality control method for polysorbate 80 in Guanxinning Injection, and provide technical support for reducing the occurrence of clinical adverse reactions.