Eco-friendly Liquid Chromatographic Method for the Estimation of Dissolution Profile of Tyrosine Kinase Inhibitors in Drug Products

A liquid chromatographic method optimized for the dissolution profiling of tyrosine kinase inhibitors (Afatinib and Ibrutinib). The method emphasizes eco-friendliness while ensuring high analytical performance by adhering to green chromatographic principles. The Afatinib and Ibrutinib showed adequate resolution on the Shimadzu Shim-pack solar C₁₈ (150 × 4.6mm, 3μm) column within 10min. The mobile phase composition involves mobile phase- A (25mM Potassium dihydrogen phosphate pH 3.0 buffer) and mobile phase-B (Ethanol: Water, in the ratio of 90: 10% V/V), pumped at a flow rate of 0.80mL/min by isocratic elution mode. Based on the obtained validation results, it is found that the optimized method is specific, linear, accurate, precise and robust. The proposed HPLC method is an excellent green method as the obtained analytical eco-scale score is 94. Based on the obtained pictograms of greenness assessment tools such as national environmental methods index label (NEMI), modified NEMI, green analytical procedure index pictogram (GAPI), complex GAPI, analytical greenness (AGREE), and AGREE preparation the method is found to be green. The eco-friendly liquid chromatographic method offers a reliable and sustainable approach for evaluating the dissolution profiles of dosage forms, significantly reducing potential harm to the environment and living organisms.