硫酸依替米星氯化钠注射液有关物质检测方法的对比研究

Comparative Study on the Determination Method of Related Substances in Etimicin Sulfate and Sodium Chloride Injection

目的 :对硫酸依替米星氯化钠注射液的有关物质进行更有效的控制。方法:新标准YBH01062014采用高效液相色谱-蒸发光散射检测法检测有关物质,原标准WS-807(x-593)-2002采用柱前衍生化HPLC-UV法检测有关物质,对比实验数据,分析哪种方法能更有效地控制其有关物质。结果:通过分析实验数据,新标准比原标准更能对硫酸依替米星氯化钠注射液的有关物质进行有效控制。结论 :新标准对硫酸依替米星氯化钠注射液的质控限度更加严格,能更好的控制药品质量,保证临床疗效。

Objective ： More effective control of related substances of Etimicin Sulfate and Sodium Chloride Injection. Methods ： The new standard YBH01062014 using HPLC - ELSD method determination of related substances, the old standard of WS - 807 （ x - 593 ） - 2002 using Pre - column derivatization HPLC - UV method determination of related substances, as compared with the experimental data, analysis what kind of method can more effectively control the related substances. Results ： Through the analysis of the experimental data, the new standards is more effective control than the old standard on the related substances of Etimicin Sulfate and Sodium Chloride Injection. Conclusion ： The related substance of new standard by Etimicin Sulfate and Sodium Chloride Injection was more strict control, better control of product quality and ensure clinical efficacy.