RP-HPLC测定IDP α晶型的含量及其有关物质  

RP-HPLC determination of content of IDP α polymorph and its related substances

作　　者：徐利君[1] 黄荣清[1] 肖炳坤[1] 杨建云[1] 

机构地区：[1]军事医学科学院放射与辐射医学研究所,北京100850

出　　处：《药物分析杂志》2010年第6期1052-1054,共3页Chinese Journal of Pharmaceutical Analysis

基　　金：国家自然基金项目(NO.20672143);国家科技重大专项"重大新药创制";综合性新药研究开发技术大平台(2009ZX09301-002)

摘　　要：目的：建立反相高效液相色谱法测定IDPα晶型的含量及其有关物质。方法：采用梯度洗脱（线性梯度）方法,色谱柱：Diamonsil C18（250mm×4.6mm,5μm）;流动相：流动相A为乙腈,B为水;检测波长为228nm;流速：1.2mL·min-1。结果：在该条件下,IDPα晶型主峰与有关物质得到了很好的分离;在10-80μg.mL-1范围内,浓度与相应的峰面积呈良好的线性关系（r=0.9999）;最低定量限和最低检测限分别为14ng和4ng。结论：本方法简便、准确,专属性好,可用于质量控制。Objective：To establish an RP-HPLC method for the determination of IDP α polymorph and its related substances.Methods：The HPLC method was conducted on a Diamonsil C18 column（250 mm×4.6 mm,5 μm）and UV detector at 228 nm.The gradient elution was used with a flow rate of 1.2 mL·min-1.The mobile phase was acetonitrile（A）and water（B）.Results：Using this method,IDP α polymorph and its related substances were well separated.The linear ranges were 10-80 μg·mL-1（r=0.9999）;the limit of detection and the limit of quantification were 14 ng and 4 ng,respectively.Conclusion：The proposed method is simple,accurate and specific for the quality control of IDP α polymorph.

关 键 词：IDP α晶型 反相高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]