*Corresponding Author: Ankit Chaudhary, Saraswati Institute of Pharmaceutical Sciences, Gandhinagar, Gujarat, India.
Background/Objectives: A robust, sensitive reversed-phase high-performance liquid chromatographic method was developed and validated for the simultaneous estimation of ticagrelor and rivaroxaban in bulk and synthetic mixture using an Analytical Quality by Design approach.
Methods: A risk-based approach was used to develop the method in order to identify an operable design region. A 3-level factorial design optimized important parameters including the ratio of acetonitrile in the mobile phase (A), flow rate (B) and column oven temperature (°C) that were auto-generated by using Design Expert 10.
Results: The separation was performed on a C18 column (250 × 4.6 mm, 5 µm) using acetonitrile: methanol (60:40 v/v) as the mobile phase at 0.8 mL/min with detection wavelength at UV 245 nm. For ticagrelor and rivaroxaban, retention times were around 3.56 and 6.69 min, respectively, with good resolution and minimal tailing. The method was validated as per ICH Q2(R2) guidelines and found to be linear in the range of 45-135 µg/mL (ticagrelor) and 2.5-7.5 µg/mL (rivaroxaban) having correlation coefficient (R²) > 0.999. The accuracy (98.2 to 101.4%), precision (%RSD < 2) and robustness of the method shown in the method operable design region were excellent. Results of environmental and operational evaluations based on criteria AGREE, Eco-Scale, and the RGB model demonstrated better greenness, less use of resource materials and better user-friendly features than the reported methods.
Conclusion: The research effectively illustrates the use of analytical quality by design thoughts in developing a robust, compliant and green analytical method for the routine analysis and quality control of ticagrelor and rivaroxaban combinations pertinent to the treatment of thromboembolic disorders.
Keywords: Ticagrelor, Rivaroxaban, RP-HPLC, Analytical Quality by Design, Design Expert 10, ICH Q2(R2).
How to cite this article: Shukla RR, Chaudhary A, Patel P, Detholia K. AQbD-driven development of a sustainable RP-HPLC method for concurrent quantification of ticagrelor and rivaroxaban: a white analytical chemistry perspective. Int J Drug Deliv Technol. 2026;16(6s): 142-153; DOI: 10.25258/ijddt.16.6s.18
Source of support: Nil.
Conflict of interest: None