注射用盐酸万古霉素有关物质检查方法的改进

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,...

Improvement of Related Substances Test Method for Vancomycin Hydrochloride for Injection

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.