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市售3种法莫替丁针剂含量及总杂质评价
引用本文:付强,李大魁,王丹阳.市售3种法莫替丁针剂含量及总杂质评价[J].中国药学杂志,2003,38(8):617-618.
作者姓名:付强  李大魁  王丹阳
作者单位:1. 中国医学科学院-中国协和医科大学北京协和医院,北京,100730
2. 大连市友谊医院,辽宁,大连,116001
摘    要: 目的对市售3种法莫替丁针剂进行质量对比性评价。方法采用HPLC测定3种法莫替丁针剂含量及总杂质,并以此按中国药典、美国药典及企标质控要求对市售3种针剂作出制剂质量评价。结果3种共10批次针剂含量分别为:(A)91.04%~95.04%,(B)97.11%~98.62%,(C)100.18%~101.15%间;总杂质占有比例分别为:(A)4.30%~8.59%,(B)0.80%~1.06%,(C)0.10%~0.12%间。法莫替丁水溶液受热分解,色谱图可见明显规定杂峰。结论3种针剂含量均在药典规定范围(水针A有1批号低于企标下限),水针剂含量有与放置时间成反比的趋势;按企标总杂质要求,4批次水针A及1批粉针B均未达标,高舒达粉针均远低于企标要求。

关 键 词:法莫替丁针剂  高效液相色谱法
文章编号:1001-2494(2003)08-0617-02
收稿时间:2002-02-26;
修稿时间:2002年2月26日

Quality evaluation of famotidine products for injection
FU Qiang ,LI Da-kui ,WANG Dan-yang.Quality evaluation of famotidine products for injection[J].Chinese Pharmaceutical Journal,2003,38(8):617-618.
Authors:FU Qiang  LI Da-kui  WANG Dan-yang
Institution:FU Qiang 1,LI Da-kui 1,WANG Dan-yang 2
Abstract:OBJECTIVE This study evaluated the quality of 2 generic famotidine products for injection with the innovator product. METHOD The content and total impurities were assayed by HPLC. RESULTS The contents of famotidine in 3 products were 91%~102%,within the claimed in the labeling,the QB (Yamanouchi),CP2000 and USP24 standards respectively.Only 1 of 4 batches of famotidine injection was below the claimed content in the label.The total impurities in one batch of famotidine for injection and 4 batches of famotidine injection were 1.06% and 4.30%~8.53% respectively,exceeded the Yamanouchi QB of 1.0% limit. CONCLUSION The total impurities played a major role to influence the quality of generic products,especially for famotidine injection due to its instability in water.
Keywords:famotidine  HPLC  quality evaluation  total impurities  
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