摘要
目的比较采用两种方法测定黄芪注射液中聚山梨酯80含量的优缺点。方法分别采用高效液相色谱-蒸发光散射检测法(HPLC-ELSD)和紫外-可见分光光度法(UV)进行检测;采用分子凝胶色谱柱;以乙腈-水(90:10)为流动相;流速为0.6 mL.min-1;漂移管温度110℃,载气流速为2.3 L.min-1。结果两种方法测得的结果之间存在系数关系,HPLC-ELSD法测得结果约为UV法的0.65;与黄芪注射液中聚山梨酯80理论投料量进行比较,HPLC-ELSD法测定结果比UV法更接近理论值。结论 HPLC-ELSD法简便、准确,更有利于黄芪注射液中聚山梨酯80的含量控制。
OBJECTIVE To compare the advantages and disadvantages of the HPLC - ELSD and UV method for determination of Polysorbate 80 in Huangqi Injection. METHODS HPLC -ELSD and UV were used for testing; The HPLC separation was carried out on a molecular gel column, using acetonitrile -water （90：10） as mobile phase. The flow rate was 0. 6 mL . min-1 ,temperature for the drift tube was 110℃ and the nitrogen flow rate was 2. 3 L. min-1. RESULTS There was a relationship between the resuhs of these two methods, that was to say, the result of UV was about 1.54 times that of HPLC - ELSD. Comparedwith the result of UV, that of HPLC - ELSD was closer to the theoretical value of Polysorbate 80 In Huangqi Injection. CONCLUSION The HPLC - ELSD was simple, accurate and more conducive to control the content of Polysorbate 80 in Huangqi Injection.
出处
《齐鲁药事》
2011年第1期19-21,共3页
qilu pharmaceutical affairs
基金
国家科技重大专项课题项目(2009ZX09502-024)
