US EPA

8335112 

Journal Article 

A chiral stationary phase HPLC method for determining ticagrelor isomers in ticagrelor tablets 

Ni, JW; Ye, HY; Zhang, M; Yang, HX 

2018 

Chinese Journal of New Drugs Co. Ltd. 

27 

5 

515-520 

Chinese 

Objective: To establish a method of high performance liquidchromatography (HPLC) with chiral stationary phase for the detection of ticagrelor enantiomer and diastereomers in ticagrelor tablets. Methods: The experiments were performed on a CHIRALPAK IA (250 mm×4.6 mm, 5 μm) column at 30℃ with the mobile phase of n-hexane-methanol-ethanol-acetic acid (800∶100∶100∶1) at a flow rate of 0.8 mL·min-1. The detection wavelength was set at 255nm. Results: All the resolutions between ticagrelor and the enantiomer, and between the enantiomer and the diastereomers were greater than 1.5. The calibration curves of ticagrelor and the isomers showed good linear relationships over the detection range with correction coefficients more than 0.999. The limits of detection (LODs) of ticagrelor and the isomers were 0.1 μg·mL-1, and the limits of quantitation (LOQs) of ticagrelor and the isomers were 0.2~0.4 μg·mL-1. The sample solutions were stable within 18 hours. The method had a good precision and robustness. Conclusion: The method is specific and sensitive, which meets the detecting demand of ticagrelor enantiomer and diastereomers in ticagrelor tablets. © 2018, Chinese Journal of New Drugs Co. Ltd. All right reserved. 

Chiral stationary phase; Diastereoisomer; Enantiomer; High performance liquid chromatography (HPLC); Ticagrelor