注射用氨苄西林钠舒巴坦钠含量测定方法的改进  

IMPROVEMENT IN ASSAY OF AMPICILLIN SODIUM/SULBACTAM SODIUM FOR INJECTION

作　　者：刘浩[1] 仇仕林[1] 

机构地区：[1]上海市药品检验所,上海200233

出　　处：《中国药品标准》2002年第3期55-57,共3页Drug Standards of China

摘　　要：目的:改进注射用氨苄西林钠舒巴坦钠含量测定方法。方法:ODS柱(150×6.0mm,5μm),流动相:含0.005mol/L氢氧化四丁基铵和0.02mol/L醋酸铵的溶液—乙腈(825:175),用冰醋酸调节pH值为5.0。结果:氨苄西林和舒巴坦的线性范围和回归方程分别为:62～1232μg/ml,C=0.31546A—10.507(r=0.9999);31～621μg/ml,C=0.75961A—2.342(r=1.0000)。本方法与药典方法的测定结果一致。结论:本方法简便、准确、耐用性好。Objective: To improve the official RP ion pair HPLC method for assay of Ampicillin Sodium/Sulbactam Sodium for Injection.Methods:HPLC method with ODS column(150×6.0mm,5μm),mobile phase:0.02mol/L ammonium Acetate solution containing 0.005mol/L tetrabuty lammonium hydroxide—acetonitrile(825:175)(adjust pH value to 5.0 with glacial acetic)and detection wavelength:230nm was used.Results:the concentration was The good linear relationship of calibration curves in the range of 62～1232μg/ml(r=0.9999)for Ampicillin and 31～621μg/ml(r=1.0000)for Sulbactam respectively.The assay results agreed with those obtained by using official method.Conclusion:The method was simple,reliable and rubust.

关 键 词：氨苄西林 舒巴坦 高效液相色谱法 含量测定 

分 类 号：R927.2[医药卫生—药学]