部分国产注射用头孢他啶与原研产品杂质研究

发布时间：2019-01-09 17:02

【摘要】：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。
[Abstract]:Objective: to study the impurity of ceftazidime for injection and ceftazidime for injection by RP-HPLC. Methods: the impurity was quantitatively determined by self-control method and the impurity structure was preliminarily identified by UPLC-MS. Results: three major impurities were detected in ceftazidime for injection, and four major impurities were detected in 5 batches of ceftazidime for injection, among which impurity 4 was unique to domestic samples. Conclusion: the impurity spectrum of ceftazidime for injection is different between the original sample and ceftazidime for injection, and they may have different synthetic routes.
【作者单位】：湖南省食品药品检验研究院;
【分类号】：R927

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