加替沙星氯化钠注射液稳定性研究.pdf

中国抗生索杂志2005年4月第30卷第4期 ·211· 加替沙星氯化钠注射液稳定性研究 黄金龙 (浙江尖蜂药业有限公可， 盎华321000) 一个光降解杂质，含量约0．0612％，该杂质被分离与鉴定．通过液相色谱／质谱联用技术确认为N，一脱环丙基物质，加替沙星氯化钠 的，也是稳定的。 关键词：加替沙星氯化钠注射液；杂质；光降解；LC—MS分析 中固分类号：R927．儿 文献标识码；A Studiesonthe of sodiumfor stabilitygatifloxacin injection Huang Jin—long Pharmaceutical (ZheJiangJianFeng Ltd．Co．，jinhua321000) ABSTRACTThe of sodiumfor was ioieetion bvHPI，C．Itwasstable stabilitygatifloxacin performed from and stable atroom fortwo Butthe heatingpracticallystoring temperatureyears． of sodiumfor hadbeen after10 witha impuilY injection produced contentabout gatifloxacin days’irradiation ofthe were anddeterminedRP—HPLC 0．0612％．The preparationseparated method．Thestrut— impurities by tureofthe was LC—MS contentofthis phot。d。gradationproductdecyclopropylcompoundby analysis．The was the hadbeenirradiatedfor10 andfurtherstoredfor at impurityO．0893％whenpreparation two days years room sodiumfor be should from temperature．Thereforegatifloxacin injection keptaway light． KEYWORDS sodiumfor Gatifloxacin injection； I。C—MS