Towards sustainable pharmaceutical QC: micellar-UPLC strategy for concomitant analysis of a cardiovascular polypill with aniline and salicylic acid impurities

Medication compliance is a key factor in achieving positive health outcomes, and this is difficult for patients, especially the elderly, who need polytherapy. Therefore, pharmacy experts have devised a single-pill combination that combines more than one active pharmaceutical ingredient to treat multiple diseases and improve patient compliance with medication. Here, an affordable UPLC approach was designed for the estimation of a fixed-dose combination that cures hypertension, hyperlipidemia, and blood coagulation and subsequently prevents heart attacks. This combination includes four active ingredients: aspirin (ASR), atorvastatin calcium (ATC), metoprolol succinate (MES), and ramipril (RAP). The applied approach was devised to determine the mentioned drugs in their commercial dosage form and also in the presence of ASR's impurity (salicylic acid) and ATC's impurity (aniline). The target drugs were separated on a Kinetex^® XB-C18 column using an isocratic micellar eluent system composed of 0.02 M Brij-35 at pH 3.0 (using orthophosphoric acid) and 10% n-propanol, flowed at 0.20 mL/min. The mentioned drugs were UV-scanned at 230.0 nm. ICH requirements were followed for all validation items. Whiteness and greenness appraisals were performed, affirming the applied approach's friendliness to the environment. The priority of this UPLC approach over the published LC ones is due to using a micellar moving phase, making it more eco-friendly to the environment, and the determination of the aforementioned drugs even in the presence of aniline (toxic impurity) and salicylic acid.