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

作　　者：李樱红[1] 黄琴伟[1] 祝明[1] 郭增喜[1] 

机构地区：[1]浙江省食品药品检验所,杭州310004

出　　处：《药物分析杂志》2012年第5期826-828,共3页Chinese Journal of Pharmaceutical Analysis

基　　金：国家科技重大专项中药质量标准研究和信息化体系建设平台(2009ZX09308-004)

摘　　要：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.

关 键 词：冠心宁注射液 聚山梨酯80 不良反应 高效液相色谱 蒸发光散射 助溶剂 质量控制 安全监测 标准完善 

分 类 号：R917[医药卫生—药物分析学]