Eco-friendly HPLC method for simultaneous determination of pantoprazole and domperidone: Comprehensive evaluation of greenness, whiteness, and blueness

Abstract

An environmentally friendly RP-HPLC method was developed for the simultaneous determination of pantoprazole (PAN) and domperidone (DOM). Chromatographic separation was performed using isocratic elution on CORTECS® Shield RP18 column maintained at 25 °C. The mobile phase consisted of ethanol and potassium phosphate buffer (50.0 mM, pH 6.0) in a 30:70 (v/v) ratio, delivered at a flow rate of 1.0 mL/min, with UV detection at 286 nm. The method demonstrated excellent linearity within the concentration ranges of 1.0–25.0 μg/mL for PAN and 3.0–30.0 μg/mL for DOM. It was successfully applied to the analysis of both drugs in bulk and pharmaceutical dosage forms. The greenness of the proposed method was evaluated using the Analytical Eco-Scale, yielding a total score of 83, which indicates minimal environmental impact. The method "whiteness" was assessed using the RGB 12 model, resulting in a high total score of 89.2, reflecting a well-balanced combination of analytical performance, environmental sustainability, and practical implementation. Its "blueness," representing practical applicability, was measured using the BAGI tool and achieved a total score of 82.5. Compared to a previously reported HPLC method, the proposed method offers comparable practical applicability while exhibiting enhanced greenness through the use of ethanol as the organic modifier, rather than environmentally hazardous solvents such as acetonitrile and methanol. The method was fully validated according to ICH Q2(R1) guidelines, confirming its accuracy, precision, specificity, and robustness. Furthermore, the proposed method was statistically compared with a previously reported HPLC method using Student’s t-test and F-test.