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HPLC法测定注射用头孢哌酮钠舒巴坦钠中两组分的含量和有关物质 被引量:8

HPLC Determination of Two Components and Related Substances in Cefoperazone Sodium and Sulbactam Sodium for Injection
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摘要 用HPLC法测定注射用头孢哌酮钠舒巴坦钠中共孢哌酮和舒巴坦的含量及其有关物质。用Zorbax SB-C18色谱柱(250mm×4.6mm,5μm);乙腈-0.03mol·L^-1磷酸二氢钾溶液10%四丁基氢氧化铵溶液(190:795:15,用磷酸调pH值为4.0)为流动相;检测波长;230hill;流速:1mL·min^-1;进样量:10μL;柱温:30℃。头孢哌酮与舒巴坦分别能与其相邻杂质峰完全分离,头孢哌酮在14.96~2695.35μg·mL^-1、舒巴坦在13.98~2796.8μg·mL^-1浓度范围内线性关系均良好(R^2=0.999、0.9993)。该法简便、准确、专属性好,可以用于注射用共孢哌酮钠舒巴坦钠中头孢哌酮和舒巴坦的含量测定及有关物质检查。 The HPLC method for the determination of eefoperazone and sulbaetam and related substances in cefoperazone sodium and sulbaetam sodium for injection was established. The HPLC system consisted of a Zorbax SB-C18 column(5μm,250 mm×4.6 mm) and a mixture of acetonitrile 0.03 mol· L^-1 potassium dihydrogen phosphate solution and 10% tetrabutyl ammonium hydroxide(190 : 795 : 15) as mobile phase. The flow rate was 1.0 mL·min^-1 with detection wavelength at 230 nm and column temperature at 30℃. Cefoperazone and sulbactam could be completely separated from other impurities. The linear range of cefoperazone was 14.96 -2695.35μg·mL^-1 and sulbactam was 13. 98 - 2796. 8μg·mL^-1 (R^2=0. 9999 and 0.9993). The method was simple,accurate and suitable for the determination of cefoperazone and sulbactam and related substances in cefoperazone sodium and sulbaetam sodium for injection.
作者 黄莉 万江陵
出处 《化学与生物工程》 CAS 2006年第1期60-62,共3页 Chemistry & Bioengineering
关键词 头孢哌酮钠 舒巴坦钠 测定 有关物质 高效液相色谱法 cefoperazone sodlum sulbactam sodium determination related substance HPLC
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