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

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 GEL G2000SWxl色谱柱(7.8 mm×300 mm,5 μm),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5.13~51.30 μg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.

1 WANG Hui(王辉).One case of advers effects by Guanxinning Injection(冠心宁注射液致不良反应一例).Med J Natl Def Force North China(华北国防医药),2006,18(4):237
2 WANG Zhi-yuan(王志远),TAO Li(陶礼),HU Xiao-yan(胡小燕).One case of bad advers effects by Guanxinning injection(冠心宁注射液致严重不良反应1例报告).Lishizhen Med Mater Med Res(时珍国医国药),2004,15(8):542
3 YANG Quan(杨泉),ZHANG Hui(张辉).One case of advers effects by Guanxinning injection(冠心宁注射液致过敏反应1例).China Pharm(中国药业),2007,16(17):33
4 WU Yi(吴毅),JIN Shao-hong(金少鸿).Progress of pharmacological properties,pharmacokinetics properties and analytic method of pharmaceutical adjuvant Tween 80(药用辅料吐温80的药理、药动学及分析方法研究进展).Chin Pharm Aff(中国药事),2008,22(8):717
5 WU Yi(吴毅),LIANG Cheng-gang(梁成罡),JIN Shao-hong(金少鸿),et al.SEC-ELSD determination of polysorbate 80 in traditional Chinese medicine injections( SEC-ELSD法测定中药注射液中聚山梨酯80的含量).Chin J Pharm Anal(药物分析杂志),2008,28(1):12
6 WANG Shao-min(王少敏),XIA Jing(夏晶),CHEN Jie(陈洁),et al.Comparative study of two kinds of methods for determination of polysorbate 80(excipients) in Huangqi injection(黄芪注射液中药用辅料聚山梨酯80两种含量测定方法的比较研究).Qilu Pharm Aff(齐鲁药事),2011,30(1):19
7 TANG Deng-feng(唐登峰),ZHU Ming(祝明),CHEN Bi-lian(陈碧莲),et al.Determination of polysorbate 80 in the zedoary turmeric oil injection by HPLC-ELSD(HPLC-ELSD测定莪术油注射液中聚山梨酯80的含量).Chin J Mod Appl Pharm(中国现代应用药学),2011,28(5):462
8 WU Xiao-yan(吴晓燕),GUO Qing(郭青),DI Liu-qing(狄留庆).Quantitative analysis and safty assessment of Tween 80 in Mailuoning injection(脉络宁注射液中聚山梨酯80的含量测定与安全性分析).Chin J Hosp Pharm(中国医院药学杂志),2011,31(7):554