Development of a quality by design based eco-friendly RP-HPLC method for Ticagrelor and Aspirin
Year: 2025
Type: article
Abstract: • QbD approach with RP-HPLC for Ticagrelor and Aspirin with minimal environmental impact is applied. • The retention times recorded for Ticagrelor and Aspirin were 2.32 and 7.56 min, respectively. • Recovery of TICA was 98.92 % and ASP was 99.75 %. • Evaluations of their environmental friendliness have been performed using GAPI, AGREE, and Analytical Eco-Scale. Ticagrelor (TICA) and Aspirin (ASP) are widely prevalent antiplatelet drugs. With growing focus on sustainable operations, there is a necessity for green and strong analytical procedures for their simultaneous estimation. To design and validate a green, QbD-based RP-HPLC technique for simultaneous estimation of TICA and ASP in drug products. A 3-factor factorial design based on Response Surface Methodology (RSM) optimized important parameters: organic solvent composition, flow rate, and column temperature. The optimized mobile phase was acetonitrile and 0.1 % trifluoroacetic acid (49:51, v/v) and detection at 225 nm. Validation was done according to ICH Q2(R2) guidelines. Green evaluation employed ComplexGAPI, AGREE, and Analytical Eco-Scale. The procedure demonstrated good linearity (TICA: 18–135 μg/mL; ASP: 15–112.5 μg/mL; R² > 0.999), high precision ( %RSD <1.5), and robustness. Green metrics were good (AGREE: 0.79; Eco-Scale: 88). A green, precise, and robust RP-HPLC method was established for the simultaneous estimation of TICA and ASP. Combination of AQbD and green tools lends support to its application in routine quality control with minimal environmental impact.
Source: Green Analytical Chemistry
Institution: Sankalchand Patel University
Language: English
Subfield: Analytical Chemistry
Field: Chemistry
Domain: Physical Sciences
Open Access status: gold
Estimated APC paid: $1,550
OpenAlex ID: W4409582723