摘要
目的:改进注射用盐酸万古霉素有关物质的检查方法。方法:采用辛烷基硅烷键合硅胶色谱柱(C8,4.6 mm×250 mm,5μm);采用梯度洗脱,流动相A的组成为三乙胺缓冲液-乙腈-四氢呋喃(96∶3∶1),流动相B的组成为三乙胺缓冲液-乙腈-四氢呋喃(70∶29∶1);流速为1 mL·min-1,检测波长为280 nm,并与盐酸万古霉素进口注册标准所载的方法进行比较。结果:采用注册标准方法与本文方法对3个批号的注射用盐酸万古霉素有关物质进行检测,结果无显著性差异(P>0.05);且该方法分离效果好。结论:本方法可用于检测注射用盐酸万古霉素的有关物质。
To improve related substances test method for vaneomycin hydrochloride for injection. Methods： An HPLC method was established for the determination the related substances for vancomycin hydrochloride for injection. The separation was a- chieved by using a chromatography column（ C8 , 4. 6 mm x 250 mm ,5μm） with gradient eluent composed of mobile phase A [ tfiethyl- amine buffer solution-aeetonitrile-tetrahydrofnran（96： 3：1 ） ] and phase B [ triethylamine buffer solution-acetonitrile-tetrahydrofuran（7（3 ： 29：1 ） ] at a wavelength o/＇280 nm and flow rate was 1 mL - rain -1. This method was compared with the import registration specifica- tions of vancomycin hydrochloride for injection. Results： There was no significant difference between these two methods in determining three batches of the vancomycin hydrochloride for injection （P 〉 0. 05 ）. Conclusion： The method is better than the import registratior specifications and can be used to determine the related substances in the vancomycin hydrochloride for injection.
出处
《中国药品标准》
CAS
2011年第6期445-447,共3页
Drug Standards of China
关键词
盐酸万古霉素
有关物质
Vancomyein hydrochloride
Related substances
