论文部分内容阅读
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1 mol·L-1的磷酸调节pH至4.0)-乙腈(750:250),流速为1 ml·min-1,检测波长为220 nm。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。
Objective: To establish a HPLC method for the determination of cefoperazone sodium and sulbactam sodium for injection and other related substances. To investigate the stability of cefoperazone sodium and sulbactam sodium for injection. Methods: ODS C18 column was used as the mobile phase. The mobile phase was 0.005 mol·L -1 tetrabutylammonium hydroxide (pH = 4.0 with 1 mol·L -1 phosphoric acid) -acetonitrile (750: 250), the flow rate was 1 ml · Min-1, the detection wavelength is 220 nm. Results: The HPLC method was established to determine cefoperazone degradation products B and other related substances in cefoperazone sodium and sulbactam sodium for injection simultaneously. The stability of cefoperazone sodium and sulbactam sodium for injection was investigated. Conclusion: The method is simple, rapid, reproducible, suitable for the quality control of the drug production and clinical application.