奥扎格雷钠氯化钠注射液中特定杂质的研究  

Study on the Specific Impurities in Ozagrel Sodium and Sodium Chloride Injections

作　　者：于明[1] 张迪[1] 李沫[1] 孙宽[1] 

机构地区：[1]辽宁省食品药品检验所,沈阳110023

出　　处：《中国药师》2012年第10期1421-1423,共3页China Pharmacist

摘　　要：目的:研究奥扎格雷钠氯化钠注射液中的特定杂质。方法:采用HPLC/MS和HPLC法对奥扎格雷钠氯化钠注射液中的特定杂质进行研究,并对44批样品进行测定。结果:初步确定了两个特定杂质的结构,44批样品中杂质Ⅰ的含量为0.06%～0.24%,杂质Ⅱ的含量为0～0.26%。结论:奥扎格雷钠氯化钠注射液中杂质Ⅰ与原料药的合成工艺有关,杂质Ⅱ为制剂中奥扎格雷钠的降解产物。Objective： To study the specific impurities in ozagrel sodium and sodium chloride injections.Method： Two specific impurities in 44 batches of ozagrel sodium and sodium chloride injections were determined by HPLC/MS and HPLC.Result： The structures of the two specific impurities were inferred.In the tested ozagrel sodium and sodium chloride injections,the content of impurityⅠand Ⅱwas 0.06%-0.24% and 0-0.26%,respectively.Conclusion： ImpurityⅠis related with the synthesis route of ozagrel.ImpurityⅡis the degradation product produced in the preparation process of the injections.

关 键 词：HPLC MS 奥扎格雷钠氯化钠注射液 杂质 

分 类 号：R917[医药卫生—药物分析学]