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机构地区:[1]上海市药品检验所,上海200233 [2]华东理工大学,上海200237
出 处:《中国抗生素杂志》2003年第11期659-662,共4页Chinese Journal of Antibiotics
摘 要:对头孢呋辛酯的HPLC含量测定方法进行改进。色谱条件:采用ODS柱,0.01mol/L磷酸盐缓冲液(pH2.0)—乙腈—叔丁基甲醚(80∶15∶5)为流动相,柱温45℃,检测波长278nm。头孢呋辛酯与有关物质分离良好。头孢呋辛酯在89~268μg/ml范围内呈良好的线性关系,日内RSD为0.4%,含量测定结果与采用欧洲药典方法所得结果相符。提出了头孢呋辛酯有关物质检查的梯度洗脱HPLC法。A modified HPLC method for the assay of cefuroxime axetil was established. The chromatographic condition were as follows: column:ODS;mobile phase:0 01mol/L phosphate buffer (pH2 0)— acetonitrile— tert- butyl methyl ether (80∶ 15∶ 5),column temperature:45℃ ,detection wavelength: 278nm.The standard curve was within the range of 89~ 268μ g/ml of cefuroxime.The precision in a day (RSD) was 0 4% .The assay results agreed with those obtained by using the pharmacopeia method.A gradient HPLC method for testing of related substances of cefuroxime axetil was suggested.
分 类 号:R917[医药卫生—药物分析学]
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