注射用磷苯妥英钠含量和有关物质的分析  

Quality Analysis of Fosphenytoin Sodium Injection

作　　者：郭跃龙[1] 

机构地区：[1]江苏省省级机关医院,南京210024

出　　处：《江苏药学与临床研究》2005年第2期29-31,共3页Jiangsu Pharmacertical and Clinical Research

摘　　要：目的　建立注射用磷苯妥英钠的含量和有关物质的分析方法,用于该产品的质量控制。方法　根据《中国药典》2 0 0 0年版二部附录ⅠB注射剂项下的要求及附录中的方法,对本品的质量进行分析;采用HPLC法测定本品中磷苯妥英钠及有关物质的含量。结果　用建立的方法对连续生产的3批成品进行考察,各项指标均符合《中国药典》2 0 0 0年版二部附录ⅠB注射剂项下的要求。结论　建立的方法可对该产品的质量进行控制。OBJECTIVE To establish a method of quality analysis of fosphenytoin sodium injection, which is applied for quality control.METHODS Quality analysis was conducted to the methods in Appendix I B of Part II, Ch.P 2000,the assay of fosphenytoin sodium and related substances was determined by HPLC.RESULT All the test specifications conducted with the established methods to the five batches of finished products conform to the requirements to injections carried in Appendix I B of Part II, Ch.P 2000.CONCLUSION This methods established can be applied to the quality control of the product.

关 键 词：磷苯妥英钠 高效液相色谱法 质量控制 

分 类 号：R927.2[医药卫生—药学]