中国药业2017，Vol.26Issue(24)：19-22,4.DOI:10.3969/j.issn.1006-4931.2017.24.006
高效液相色谱法测定替格瑞洛含量
Content Determination of Ticagrelor by HPLC
摘要
Abstract
Objective To establish an HPLC method for content determination of Ticagrelor.Methods The Agilent ZORBAX SB-C18 column (250 mm×46 mm,5 μm) was adopted,the mobile phase was acetonitrile-water (50∶50),the detection wavelength was 254 nm,the column temperature was 35 ℃,and the flow rate was 1.0 mL/min.Results The resolutions between the main peak and the front and back impurity peaks were 2.95 and 5.29,the RSD of sample precision was 0.07％.When the chromatographic conditions change slightly,the resolutions between the main peak and the front and back impurity peaks were more than 1.5.The linear range of mass concentration was 0.030 05-0.450 75 g/L,and the linear regression equation was Y=17 202X-29.492,R2=0.998 9.The RSD of the repeatability test was 0.10％,and the RSD of the intermediate precision test was 0.21％,the recovery rate was in the range of 98.32％-100.86％,RSD =0.95％.Conclusion The method is simple,accurate and reproducible,which can be used to control the content of the active pharmaceutical ingredient(API) of Ticagrelor.关键词
高效液相色谱法/替格瑞洛/原料药/含量测定Key words
HPLC/ticagrelor/active pharmaceutical ingredient/content determination分类
医药卫生引用本文复制引用
郭盼,吕久安,张克军,张凯,彭效明,晁建平..高效液相色谱法测定替格瑞洛含量[J].中国药业,2017,26(24):19-22,4.基金项目
国家青年科学基金资助项目[21406015]. （）
