雷嘉川，余建清，张玲莉，柯贤炳¹

（武汉大学人民医院药学部，武汉430060; ¹武汉大学药学院2002级研究生）

   摘要  目的：建立HPLC法测定注射用头孢哌酮钠舒巴坦钠降解物等有关物质的方法。考察注射用头孢哌酮钠舒巴坦钠的稳定性。方法：以ODS C₁₈柱为分析柱，流动相为0.005 mol·L ^-1四丁基氢氧化铵(用1mol·L^-1的磷酸调节pH至4.0)  -乙腈（750：250），流速为1ml·min^-1，检测波长为220nm。结果：建立的HPLC方法，可同时测定注射用头孢哌酮钠舒巴坦钠中的头孢哌酮降解物B、头孢哌酮S异构体和其它有关物质。考察了注射用头孢哌酮钠舒巴坦钠的稳定性。结论：该法简便、快速、重现性好，适合于该药生产及临床应用的质量控制。

   关键词  头孢哌酮钠舒巴坦钠；有关物质；稳定性；高效液相色谱法

Study on Related Substances of Cefoperazone

 Sodium and Sulbactam Sodium for Injection and  Its Stability by HPLC

ABSTRACT Objective: A HPLC method was established for detect the degradation-B of cefoperazone ,vice-product and other related substances. To study the stability of cefoperazone sodium and sulbactam sodium for injection. Methods: The analytical Column was a C₁₈ reversed-phase column. The mobile phase was composed of 0.005 mol·L^-1 tetrabutylammonium hydroxide (adjusted to pH 4.0 with 1 mol·L^-1 phosphoric acid )and acetonitrile (750:250,v/v).The flow rate was 1.0 mol·L^-1 and the detection was carried out with an ultraviolet detector (λ=220nm).Results: The established method can detect degradation-B of cefoperazone,s-isomer of cefoperazone and other related substances.The stability of cefoperazone sodium and sulbactam sodium for injection was relatively good. Conclusion: This method was simple, convenient , fast, and can be applied for manufacturing and medicinal study.