HPLC法检测磺胺嘧啶银乳膏中的有关物质

Determination of Related Substances in Sulfadiazine Silver Cream by HPLC

目的建立用HPLC法检测磺胺嘧啶银乳膏中的有关物质。方法用十八烷基硅烷键合硅胶为填充剂;乙腈-0.1%磷酸溶液(9∶91)为流动相A,以甲醇为流动相B;检测波长为264 nm,进样量:5μL。结果该色谱系统能有效分离经降解的各杂质峰及主峰,磺胺嘧啶银的检测限为1.25 ng,本方法可检测到0.05%以上的杂质。结论本法专属性强,操作简便,灵敏,可用于磺胺嘧啶银乳膏中的有关物质检查。

OBJECTIVE To establish a method to determine the related substances in sulfadiazine silver cream by HPLC.METHODS An HPLC analysis method was established with a column packed with octadecylsilanized silica gel,a mixture of acetonitrile- 0. 1% phosphoric acid（9∶ 91） as the mobile phase,methanol as the mobile phase B,the detection wavelength was 264 nm,the sample size was 5 μL. RESULTS The sulfadiazine main peak was effectively separated from degradation substance peaks.The detection limits for sulfadiazine silver was 1. 25 ng. CONCLUSION The method is simple,sensitive,and it can be used for quality control of sulfadiazine silver cream.