HPLC方法测定注射用丹酚酸A中丹酚酸A的含量  

HPLC determination of salvianolic acid A in its injection

作　　者：李志刚 倪广才 孙学伟 丁锐[2] 余立[2] 

机构地区：[1]北京本草天源药物研究院,北京100039 [2]北京市药品检验所,北京100035

出　　处：《中国新药杂志》2013年第7期762-764,共3页Chinese Journal of New Drugs

基　　金：国家"重大新药创制"科技重大专项(2011ZX09102-002)

摘　　要：目的:建立注射用丹酚酸A的HPLC含量测定方法。方法:采用高效液相色谱法,使用德国MN-C18(250 mm×4.6 mm,5μm)色谱柱,以乙腈-0.2%乙酸水溶液为流动相进行梯度洗脱,流速1.0 mL.min-1,检测波长286 nm。结果:丹酚酸A线性范围为10.93～218.60μg.mL-1(r=0.999 9),高、中、低3种不同浓度的回收率分别为99.5%,99.4%和99.3%。结论:本法精密度好,结果准确、可靠、灵敏,可用于注射用丹酚酸A的含量测定。Objective： To develop a method for the determination of content of salvianolic acid A. Meth- ods： Analysis was carried out on a MN-Cls column （250 mm x 4.6 mm, 5 μm）. The mobile phase was acetonitrile and water containing 0.2% acetic acid in gradient elution. The flow rate was 1.0 mL. min-1, and the detection wavelength was set at 286 nm. Results： The calibration curve of salvianolic acid A was linear in the range of 10.93-218.60 μg mL-l（r = 0. 999 9）, and the average recoveries of its high, middle and low concentrations were 99.5% , 99.4% and 99.3% , respectively. Conclusion： The established method is accurate, credible and sensitive, and can be used for controlling the quality of salvianolic acid A for injection.

关 键 词：新药 高效液相色谱法 注射用丹酚酸A 含量测定 梯度洗脱 

分 类 号：R927.2[医药卫生—药学]