HPLC测定丹参素冰片酯脂肪乳注射液含量及有关物质  

HPLC determination of content and related substances of Danshensu Borneol Ester fat emulsion injection

作　　者：刘海静 王雨轩[2] 李霞 张亚军[3] 惠民权[3] 郑晓晖[3] 

机构地区：[1]陕西省食品药品检验所,西安710061 [2]陕西中医学院,咸阳712046 [3]西北大学中草药现代化研究及工程中心,西安710069

出　　处：《药物分析杂志》2012年第5期788-792,共5页Chinese Journal of Pharmaceutical Analysis

基　　金：科技部国家"十一五"规划重大新药创制专项课题(项目编号:2009ZX09103-121);陕西省"13115"科技创新工程重大科技专项(项目编号:2007ZDKG-70)

摘　　要：目的:建立丹参素冰片酯脂肪乳注射液含量测定及有关物质检查方法。方法:采用高效液相色谱法。色谱柱:KromasilC18(150 mm×4.6 mm,5μm)色谱柱,流动相:乙腈-0.2%甲酸水(42︰58),流速为1.0 mL·min-1,检测波长280 nm,进样体积20μL。结果:试验结果表明,HPLC法检测主峰与杂质峰有较好的分离度,且重复性较好;丹参素冰片酯的浓度在5～60μg·mL-1范围内与峰面积呈良好线性关系(r=1.000),平均回收率为98.2%(n=9)。结论:该法操作简便,结果可靠,适用于丹参素冰片酯脂肪乳注射液含量测定及有关物质检查。Objective：To establish a method to determine the content and related substances of Danshensu Borneol Ester fat emulsion injection.Methods： The experimental conditions were as follows： Kromasil C18 column（150 mm×4.6 mm,5 μm）,acetonitrile-0.2% formic acid in water（42︰58） as mobile phase,the flow rate： 1.0 mL·min-1,the injection volume： 20 μL,and detection wavelength was set at 280 nm.Results： The main peak and impurity peaks have good resolution and repeatability.The calibration curve was linear in the range of 5-60 μg·mL-1（r=1.000）.The average recovery was 98.2%（n=9）.Conclusion： The method is simple,rapid,sensitive and accurate.It is suitable for determination of the content and related substances of Danshensu Borneol Ester fat emulsion injection.

关 键 词：高效液相色谱法 丹参素冰片酯 脂肪乳注射液 静脉给药制剂 含量测定 有关物质 

分 类 号：R917[医药卫生—药物分析学]