DoE-empowered development and validation of an environmentally sustainable RP-HPLC method for simultaneous estimation of antihypertensive drugs: AQbD perspective

Abstract

AbstractThe primary objective of the present inquiry is to formulate a sustainable method employing Reverse Phase-High Performance Liquid Chromatography (RP-HPLC) for determination of Amlodipine (AM) and Irbesartan (IRB) simultaneously, compounds commonly prescribed for hypertension treatment. Existing literature underscores the absence of a comprehensive method in this regard. This research endeavors to align with the tenets of green chemistry by seamlessly integrating Analytical Quality by Design (AQbD) with RP-HPLC, replacing environmentally hazardous chemical modifiers with eco-friendly solvents. Identifying the critical variables as the 70% ethanol level and flow rate, a central composite design is applied for optimization. The separation is achieved utilizing a Phenomenex Luna column (C18, 250 mm × 4.6 mm i.d, 5 μm) with a mobile phase comprising ethanol and 0.1 % o-phosphoric acid in a 70:30 v/v ratio, flowing at 0.8 mL min−1, and detection wavelength of 242 nm. Green assessment methodologies are implemented to gauge the adherence of the proposed RP-HPLC method to eco-friendly principles while ensuring efficiency in chromatographic performance. The current developed method is rapid with retention time of 2.3 and 3.3 min for AM and IRB respectively and having a wide linear range from 55 to 130 μg mL−1, which makes the suitable for the accurate quantification of AM and IRB simultaneously in bulk and tablet dosage form, there by minimize environmental impact by providing a conscientious choice for the routine analysis which is achieved through the amalgamation of AQbD with a sustainable approach.