舒巴坦钠相关物质高效液相色谱分析

The analysis of related substances in Sulbactam Sodium by HPLC

舒巴坦钠本身抑菌作用较弱,是一种竞争性、不可逆的β-内酰胺酶抑制剂药,通常与头孢哌酮钠、氨苄西林钠、阿莫西林钠、哌拉西林钠等联合应用;舒巴坦可防止耐药菌对青霉素类和头孢菌素类抗生素的破坏,舒巴坦与青霉素类和头孢菌素类抗生素具有明显的协同作用。国内通常采用中国药典2005年版相关物质的检测方法进行检测,经检测不同生产厂家的舒巴坦钠,在主成分峰保留时间的3倍停止后,通常在7倍左右还有其杂质,不能够完全洗脱,完成一个样品的杂质分析需要近50分钟。现采用梯度的洗脱方法,不仅缩短了检测的时间,还可对其杂质进行定性,为指导生产过程中的杂质控制,提供了可靠的数据。

Sulbactam Sodium is a competive and inconvertible beta-lactamaae inhibitor with very weak antibacterial action. It is usually used together with Cefoperazone Sodium, Cmpicillin Sodium, Amoxicillin Sodium and Piperacillin Sodium, etc. The compound prevents antibiotic destruction of beta-lactam antibiotics and possesses conspicuously synergistic effect with penicillins and cephalosporins. In China, the detection of related substances usually deploy the method recorded in CP （2005）. However, some disadvantages appeared when we detected Sulbactam Sodiums come from different factorys according to the method mentioned above. After three times of principal constituent＇s retention time, some impurity which can＇t be eluted completely appeared at the time of seven times of principal constituent＇s retention time. Thus, it cost nearly 50 minutes for impurity detection of one sample. To improve the method of impurity detection for Sulbactam Sodium, we established a HPLC method adopt gradient elution, which not only shorten the detection time, but also possess the ability of impurity qualitation. It will provid reliable data for the control of impurity in Sulbactam Sodium production.