摘要
目的:用 HPLC 法测定注射用头孢哌酮钠他唑巴坦钠中头孢哌酮和他唑巴坦的含量及其有关物质。方法:用 ZorbaxSB-C_(18)色谱柱(4.6/mm/×250mm,5μm);乙腈-0.03 mol·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 为4.0)为流动相;检测波长:230nm;流速:1 mL·min^(-1);进样量:10 μL。柱温:30℃。结果:头孢哌酮与他唑巴坦分别与其相邻杂质峰能完全分离,头孢哌酮在14.96～2695.35μg·mL^(-1)、他唑巴坦在13.98～2796.8μg·mL^(-1)浓度范围内线性关系均良好,r 分别为0.9999和0.9993。结论:该法简便、准确、专属性好,可以用于注射用头孢哌酮钠他唑巴坦钠中头孢哌酮和他唑巴坦的含量测定及有关物质检查。
Objective：To establish the HPLC method for the determination of cefoperazone and tazobactam and its related substances in cefoperazone sodium and tazobactam sodium for injection. Methods：The HPLC system consisted of a Zorbax SB - C18 column（4. 6 mm ×250 mm,5 μm） 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 ℃. Results：Cefoperazone and tazobactam could be completely separated from other impurities. The linear range of cefoperazone was 14. 96 -2695.35μg · mL^-1 （r =0. 9999） and tazobactam was 13.98 -2796. 8 μg · mL^-1 （r =0. 9993）. Conclusion ：The method is simple,accurate and it is suitable for the determination of cefoperazone and tazobactam and related substances in cefoperazone sodium and tazobactam sodium for injection.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2005年第11期1364-1366,共3页
Chinese Journal of Pharmaceutical Analysis
