反相高效液相色谱法测定对氨基水杨酸钠片的有关物质  

RP-HPLC Determination of Related Substances of Sodium Aminosalicylate Tablets

作　　者：邓梅 黄洁 单敏 

机构地区：[1]陕西省西安市食品药品检验所,陕西西安710054

出　　处：《中国药业》2012年第19期41-42,共2页China Pharmaceuticals

摘　　要：目的建立测定对氨基水杨酸钠片中有关物质的反相高效液相色谱法。方法采用Phenomenex Luna C18柱(150 mm×4.6 mm,5μm),流动相为甲醇-10%四丁基氢氧化铵溶液-0.05 mol/L磷酸氢二钠-0.05 mol/L磷酸二氢钠(200∶19∶400∶400),流速1.0 mL/min,检测波长280 nm。结果对氨基水杨酸钠与间氨基酚分离度良好,间氨基酚质量浓度在0.365～1.825μg/mL之间与峰面积线性关系良好,检测限为0.012μg/mL。结论该方法简便、准确,专属性好,灵敏度高,可作为对氨基水杨酸钠片有关物质的检查方法。Objective To establish an HPLC method for the determination of related substances of Sodium Aminosalicylate Tablets. Methods The Phenomenex Luna C ls column（150 mm x4.6 mm, 5 μm） was adopted with methanol 10% tetrabutyl ammonium hydrox ide solution 0. 05 mol/L disodium hydrogen phosphate 0. 05 mol/L sodium dihydrogen phosphate （200 ： 19 ： 400 ： 400） as the mobile phase at the flow rate of 1.0 mL/min, the detection was set at 280 nm. Results Good separation of sodium aminosalicylate and aminophenol was achieved. The mass concentration of aminophenol in 0. 365 1. 825 μg/mL showed good linear ralation with the peak area. The detection limit was 0. 012 μg/mL. Conclusion This method is simple, accurate and highly sensitive with good specificity selective, which can be used the detection method of related substances of Sodium Aminosalicylate Tablets.

关 键 词：高效液相色谱法 对氨基水杨酸钠片 有关物质 间氨基酚 

分 类 号：R927.2[医药卫生—药学] R978.3