Environment‐Friendly High‐Performance Liquid Chromatography Method for Simultaneous Determination of Six Drugs Used for Common Cold Treatment in Different Pharmaceutical Dosage Forms

Abstract

ABSTRACT A sustainable and environmentally benign reversed‐phase high‐performance liquid chromatography method was developed for the simultaneous determination of six widely used anti‐cold drugs: pseudoephedrine hydrochloride, paracetamol, caffeine, cetirizine dihydrochloride, guaifenesin, and ibuprofen. The method was designed in accordance with green analytical chemistry concepts, allowing the simultaneous analysis of multiple components in a single chromatographic run within a short analysis time. Notably, the procedure eliminates the need for derivatization or prior sample preparation and operates with relatively low energy requirements. Chromatographic separation and quantification were achieved using a reversed‐phase C18 column. The mobile phase system consisted of ethanol as solvent A and 0.1% aqueous acetic acid as solvent B, delivered through a simple gradient elution program at a flow rate of 1.2 mL/min. Detection was performed using an ultraviolet detector set at 215 nm. Validation of the developed method was carried out following International Council for Harmonization guidelines, confirming its linearity, selectivity, sensitivity, accuracy, precision, and robustness. The applicability of the method was demonstrated through successful analysis of 12 different pharmaceutical formulations, including tablets, capsules, and oral drops. The results showed excellent selectivity and accuracy, with no interference observed from common excipients. Overall, the proposed method offers a reliable and environmentally friendly alternative for routine quality control analysis of the investigated drugs. Evaluation of its environmental impact using the National Environmental Methods Index, Green Analytical Procedure Index, and Analytical GREEnness Metric Approach tools revealed a high level of greenness, with an Eco‐Scale score of 92, indicating excellent environmental compatibility.