Determination of the Related Substances in Ticagrelor Tablets by HPLC
- VernacularTitle:HPLC法测定替格瑞洛片中有关物质的含量
- Author:
Shan HUANG
;
Mengze ZHANG
- Publication Type:Journal Article
- Keywords:
Ticagrelor;
Related substances;
HPLC
- From:
China Pharmacist
2016;19(4):814-816,821
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To establish a method for the determination of the related substances in ticagrelor tablets. Methods:An op-timal HPLC method was set up and a Hypersil BDS C18 column (200 mm × 4. 6 mm, 5μm) was adopted. The mobile phase A was wa-ter (pH was adjusted to 3. 0 by phosphoric acid) and the mobile phase B was acetonitrile with gradient elution at a flow rate of 1. 0 ml ·min-1 , and the detection wavelength was set at 255 nm. The column temperature was 30 ℃, and the volume of injection was 5 μl. Results:The resolutions between ticagrelor and the adjacent impurity ( impurity E) , and between ticagrelor and the known impurities were all greater than 1. 5. Impurity A-H all had a good linear relationship within the range of 2. 0-20. 0 μg·ml-1(r>0. 996 0). The average recovery was 99. 8%, 98. 1%, 96. 5%, 101. 2%, 99. 3%, 100. 7%, 102. 1% and 103. 4% with RSD of 1. 02%, 0. 88%, 1. 13%, 0. 56%, 0. 79%, 1. 11%, 0. 63% and 1. 39%, respectively(n=9). Conclusion:The method is reproducible and accurate in the determination of the related substances in ticagrelor tables.
