实验研究不同厂家注射用加替沙星的产品质量

Experimental studies about quality of products of Gatifloxacin for Injection produced by different pharmaceutical manufactures

目的：研究不同厂家注射用加替沙星的产品质量,为医院提供用药参考。方法：采用HPLC法测定几家注射用加替沙星的含量和有关物质;观察其在40℃RH75%6个月和室温（10-35℃）留样12个月的产品稳定性;根据《中国药典》评价产品质量。结果：采用HPLC法在293nm波长处测定其含量和有关物质,在5.0-80.0μg/ml范围内浓度与其峰面积呈良好的线性关系（r=0.9996）;在各项专属性试验中,加替沙星与其他杂质峰基线均分离良好,有关物质检测限为5ng（S/N=3）;4家产品均稳定,有效期在2年以上。结论：4家注射用加替沙星产品质量均符合《中国药典》（二部）2000年版和2005年版的要求。

Objective：To study the qualities of Gatifloxacin for Injection produced by different phamaceutical manufacturers in order to provide references to hospitals for application. Methods： HPLC was used to determine the content of gatifloxacin and related substances in the Gatifloxacin for Injection; to investigate the stabitity of Gatifloxacin for Injection from different manufactures at 40℃ RH75% 6 months and at 10-35℃ 12 months; to evaluate the quality of products about injection by the Chinese Pharmacopeia. Results： The content of gatifloxacin and related substances were determined by HPLC at 293 nm. The detectable concentration of gatifloxacin showed a good linear correlation in the range of 5.0-80.0μg/ml, r=0.999 6. All the chief peaks of gatifloxacin and those of their related substances could be well isolated in all the specificity test and the detective limit was 5 ng （S/N=3）. Products from these 4 manufacturers presented a stable state with a validity time all over 2 years. Conclusion： Quality of products manufactured by 4 manufacturing factories all accord with requirements of the Chines Pharmacopeia （the second part） of 2000 and 2005 edition.