HPLC测定磺胺醋酰钠有关物质方法的建立  

Determination of Related Substances in Sodium Sulfacetamide by HPLC

作　　者：岳志华[1] 张红[1] 张娜[1] 

机构地区：[1]中国药品生物制品检定所,北京100050

出　　处：《中国药品标准》2008年第6期427-429,共3页Drug Standards of China

摘　　要：目的:建立HPLC法测定磺胺醋酰钠中磺胺及其他有关物质方法。方法:采用岛津VP-ODSC18柱(4.6mm×150mm,5μm),磷酸盐缓冲液(0.025mol·L-1磷酸二氢钠溶液,用磷酸调pH为3.0)-甲醇[90∶10]为流动相;流速:1.0mL·min-1;检测波长:254nm;柱温为室温;结果:磺胺醋酰钠和磺胺及其他有关物质分离度良好,磺胺醋酰钠及磺胺的最低定量限分别为5和2ng。结论:本法简便、准确、专属性好,灵敏度高,可用于磺胺醋酰钠中磺胺及其他有关物质的检查。Objective：To establish an HPLC method to determine Sulfanilamide and other related substances in Sodium Sulfacetamide. Method：The HPLC method was conducted on a Shimadzu VP-ODS C18 column（4. 6 mm×150 mm ,5 μm）and coupled UV detector at 254 nm,using 0. 025 mol · L^1 NaH2PO4 buffer（adjusted to pH 3.0 with phosphoric acid）- methanol （90： 10） as mobile phase. The flow rate was 1.0 mL·min^-1 and the column temperature was room temperature. Result：The resolution between Sodium Sulfacetamide and Sulfanilamide was satisfied, and the LOD of Sodium Sulfaeetamide and Sulfanilamide were 5 and 2 ng, respectively. Conclusion： A simple , accurate and sensitive HPLC method to determine Sulfanilamide and other related compounds in Sodium Sulfacetamide was established.

关 键 词：高效液相色谱 磺胺醋酰钠 磺胺 有关物质 

分 类 号：R988.1[医药卫生—药品] R927.2[医药卫生—药学]