HPLC法测定磺苄西林钠中的有关物质.pdfVIP

• 212 中嗣抗生素杂志2008 年4 月第 33 卷第4 期 文章编号:1∞1-8689(2∞8)04-0212-02 分析、质控与制剂 HPLC 法测定磺节西林锅中的有关物质 代丽萍胡林 (成都英创科技发展有限责任公司， 成都 610041 ) 摘要: 固的 采用反相高效液相色谱法测定磺余四林纳的有关物质。方法 用 Diamonsj}(相)C..(250mm X 4. 6mm.5协m)校为分 析柱.甲醇: O. 02mollL 磷酸二氧惆辍冲液(加入0.5% 的五乙肢， 10% 磷酸调 pH4. 0) (68: 32) 为流动相;检测波怯为 220nm 温度 ô 30C。结果 最低检出限为1. 8ng; 线性范周 2.75 - 1l0mg/L( r =0.9999); 意策性实验 RSD 为 3.67% ;有关物质回收率 R5D 为 7.34% 。结论本方法准确、简便，可用于测定磺管西林纳中的有关物质。 关键词: 磺智丽林销; 有关物质; 异构体; RP-HPLC; 测定 中朋分类号:阳27.2 文献标识码: A Determination of related substances in sulbenicillin by HPLC Dai Lí-ping and Hu Lin (Chengdu Entry 5T Development Co..μ.d. ， Chengdu 610041 ) ABSTRACT Objective To establish an HPLC method for determination of related suhstances in sulbeni- cillin. Method 响le Diamonsil(n!) C18 (250mm x 4. 6mm , 5JJ.m) column was used. The mobile phase w副 methanol: O.02mo 1lL potassium dihydrogen phosphate solution(adding 0.5% TEA , then adjust to pH4.0 with 10% phosphoric acid) (32: 68 , V/ V). The detectíon wavelen阱 was 翩翩 220nm， and the column temperature was 30CC. Resul臼 The lowest detection limít was 1. 8ng; The líner range was from 2. 75 to 110mg/L( r =0.9999) , and the RSD of the repeatabìlíty test was 3.679毛 (n 嚣 6). Conclusion This method is simple, accurate and can be used for the determi- nation of related substances in sulbenicillin. KEY WORDS Sulbenicillin; Related sustances; lsomers; RP-HPLC; Determination 横节西林饷(sulbenícillin ， 1) 属广谱半合成耐酶 1 仪器