HPLC method for simultaneous analysis of ticagrelor and its organic impurities and identification of two major photodegradation products

Abstract A simple, fast and sensitive analytical method by high-performance liquid chromatography (HPLC) was developed and validated for the simultaneous determination of ticagrelor and two synthesis impurities. The HPLC method was established using an Agilent 1200 Series equipment coupled to photodiode array detector (PDA) at 270 nm with a Zorbax Plus C 8 column (150 × 4.6 mm, 5.0 μm), injection volume of 20 μL, and a constant temperature of 25 °C. The mobile phase consisted of acetonitrile: ammonium acetate 50 mM (57:43, v/v) and pH adjusted to 8.2 with ammonium hydroxide 6 M, at a flow rate of 0.7 mL/min. No interference peaks from excipients and diluent system indicated the specificity of the method. The calibration curves showed determination coefficients (r 2 ) > 0.99, calculated by linear regression. The limit of quantitation (LOQ) for impurities 1 and 2 were 2.0 and 0.2 μg/mL, respectively. Intra and interday relative standard deviations (RSDs) were