A synergistic framework for development of green HPLC methods for determination of amlodipine besylate and candesartan cilexetil in presence of their hydrolytic degradation products in two different matrices

Abstract

The world is changing so fast towards rationalization of resources consumption and employing safer practices for the surrounding environment and humans. Therefore, there is a renewed interest in integrating green analytical chemistry principles and experimental design methodologies for screening and optimizing complex analytical procedures such as HPLC. Thus, this work introduces three sustainable versatile multi-analyte HPLC methods with two types of detection techniques. Firstly, amlodipine besylate and candesartan cilexetil with three of their hydrolytic products were chromatographed on CSH-C18 (150 mm) stationary phase within short run time (about 8.9 min) through gradient elution mode, flow rate 1 mL min−1 and UV-detection at 210 nm and 254 nm. Face-centered composite design and Derringer's desirability function were implemented to optimize the chromatographic conditions to fit the goals of pharmaceutical and biological analysis via fluorometric detection. A good separation was obtained utilizing HSS-Cayno (250 mm) column and mobile phase composed of ethanol and phosphate buffer, pH 3.5, (55.6: 44.4, v/v) delivered at 1.03 mL min−1 at 245 and 446 nm as excitation and emission wavelengths, respectively, with quantification range of 1.00–400.00 ng mL−1 for amlodipine and 1.00–600.00 ng mL−1 for candesartan cilexetil. The conditions were modified for plasma analysis to a new ratio (45:55, v/v) pH 3.7 and flow rate 0.7 mL min−1. The methods' greenness profiles have been evaluated and compared with the reported ones via several comprehensive tools.