HPLC法测定一种吡唑并嘧啶类原料药WL的含量和有关物质  

Determination of Crude Drug WL and Its Related Substances by HPLC

作　　者：韩霖[1,2] 杨建云[2] 张帅[2,3] 肖炳坤[2] 黄荣清[2] 张养军[2] 

机构地区：[1]广西医科大学药学院,南宁530021 [2]军事医学科学院放射与辐射医学研究所,北京100850 [3]江西中医学院,南昌330004

出　　处：《现代科学仪器》2013年第2期121-123,共3页Modern Scientific Instruments

基　　金：十二五国家科技重大专项"重大新药创制"综合性新药研究开发技术大平台(2012ZX09301003-001-010);国家自然科学基金项目(81072613)

摘　　要：目的建立高效液相色谱法,测定一种吡唑并嘧啶类原料药WL的含量和有关物质。方法采用Diamonsil C18(250mm×4.6mm,5μm)色谱柱,以乙腈-水(40:60)为流动相,流速1.0mL/min,检测波长269nm,柱温为室温。结果 WL检测浓度在8～120μg/mL范围内与峰面积积分值呈良好的线性关系(r=0.9999);平均含量为99.5%,有关物质与主峰之间的分离度良好。检测限和定量限分别为2.16ng和7.2ng。结论本法快速、简便、准确,专属性好,灵敏度高,可用于原料药WL的质量控制。Objective An HPLC method for determination of crude drug WL and its related substances are developed.Method HPLC with Diamonsil C18 column（250mm×4.6mm was used,5μm）,the mobile phase was acetonitrile-water（40：60） at the flow rate of 1.0 ml/min;the wavelength used for detection was 256 nm and the column temperature was room temperature.Results The standard curve was rectilinear in the range of 8μg/mL^120μg/mL（r=0.9999）.The average content was99.5%.Good separation of WL and its related substances could be achieved.The limit of detection and quantification were 2.16 ng and 7.2 ng.Conclusion This method is rapid,simple,accurate,selective and sensitive.It can be used for the quality control of crude drug WL.

关 键 词：高效液相色谱 含量测定 有关物质 

分 类 号：R692[医药卫生—泌尿科学]