注射用硫酸奈替米星质量标准研究  

Study on Quality Standard of Netilmicin Sulfate for Injection

作　　者：陈星[1] 

机构地区：[1]福建省药品检验所,福州350001

出　　处：《海峡药学》2010年第7期67-70,共4页Strait Pharmaceutical Journal

摘　　要：目的修订注射用硫酸奈替米星质量标准,对试行标准进行了标准提高工作。方法改进TLC法对有关物质进行限度检查,采用费休氏水分法测定水分。结果 DTLC法专属性强,杂质斑点与主斑点分离良好,且杂质斑点清晰。费体氏水分法测定样品快速,准确,重现性好。结论方法简便,准确,重现性好,可作为注射用硫酸奈替米星的质量控制方法 。OBJECTIVE To improve the quality standard of Netilmicin Sulfate for injection. METHODS The optimized TLC method was used to determinate related substances in Netilmicin Sulfate for injection. Fischer＇s method was adopted for water determination. RESULTS The developed TLC method showed strong specificity. The spots were fairly clearand well separated. Water determination of Netilmicin Sulfate for injection by Fischer＇ s method was rapid, accurate and reproducible. CONCLUSION The methods were simple, accurate, repeatable and suitable for the quality control of Netilmicin Sulfate for injection.

关 键 词：注射用硫酸奈替米星 质量标准 薄层色谱 有关物质 水分 

分 类 号：R927.2[医药卫生—药学]