部分国产注射用头孢他啶与原研产品杂质研究

Impurities in original and domestic products of ceftazidime for injection

目的:采用反相高效液相色谱法对部分国产注射用头孢他啶和原研注射用头孢他啶的杂质进行研究。方法:采用自身对照法对杂质进行定量测定,并用UPLC-MS初步鉴定杂质结构。结果:原研注射用头孢他啶检出3个主要杂质,5批国产注射用头孢他啶均检出4个主要杂质,其中杂质4为国产样品特有杂质。结论:原研样品与国产注射用头孢他啶杂质谱不同,两者可能具有不同合成路线。

Objective： To investigate the impurity in original and several domestic products of ceftazidime for injection by reversed phase high performance liquid chromatography （RP-HPLC）. Methods： The impurities were quantitatively determined using principal self-controlled method at the same time, and each constituent of im- purity profile was identified by UPLC-MS. Results： Three common impurity peaks were detected in the original ceftazidime for injection, and 4 common impurity peaks in domestic products. The impurity 4 was detected only in the domestic sample. Conclusion ： The impurity profile of the original product is different from that of the domestic ceftazidime, indicating that they may have different synthetic routes