HPLC法梯度洗脱测定舒巴坦钠有关物质  

Determination of Related Substances in Sulbactam Sodium by Gradient Elution of HPLC

作　　者：应国红[1] 王铁杰[1] 邓颖[1] 刘敏[1] 

机构地区：[1]深圳市药品检验所,深圳518029

出　　处：《中国药品标准》2010年第2期118-121,共4页Drug Standards of China

摘　　要：目的:建立非离子色谱系统梯度洗脱的高效液相色谱法测定舒巴坦钠有关物质。方法:以C18色谱柱,5.44g.L-1磷酸二氢钾溶液(pH4.0)及乙腈分别为流动相A、B;流速为1.0mL·min-1,检测波长215nm,柱温30℃,梯度洗脱。结果:本法可有效分离舒巴坦钠的有关物质,检测限为2.8ng。结论:本法方法简单,结果准确,专属性及耐用性好。Objective： To establish a method for determination of related substances in Sulbactam Sodium by using gradient elution of HPLC. Methods： C18 column was used, 5.44 g · L^-1 potassium dihydrogen phosphate solution （pH 4. 0） and acetonitrile were used as mobile phase A and B at the flow rate of 1.0 mL · min^-1 , the detection wavelength was 215 nm. The column temperature was 30 ℃ and gradient elution was used. Results： Some impurities were obviously separated under the chromatographic system described above and the detection limit is 2. 8 ng. Conclusion： It＇ s a simple, accurate and attribute method.

关 键 词：舒巴坦钠 高效液相色谱法 梯度洗脱 有关物质 

分 类 号：R[医药卫生]