GREENNESS-ASSESSED ULTRAVIOLET AND REVERSED-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY METHODS FOR AZELNIDIPINE–METOPROLOL SUCCINATE QUANTIFICATION IN TABLETS

Objective: To ensure the quality control of fixed-dose antihypertensive formulations, it is essential to simultaneously estimate azelnidipine and metoprolol succinate. Although various methods of analysis have been reported, most of them use toxic organic solvents and have not been systematically evaluated with regard to the environment, and thus, there is a need to find greener and more reliable alternatives. The aim was to develop, validate, and simultaneously determine azelnidipine and metoprolol succinate in tablets. Methods: The ultraviolet (UV) analysis was carried out by analyzing the area under the curve and determining the zero-point crossings of the first-order derivative, using ethanol as the solvent. Reversed-phase high-performance liquid chromatography (RP-HPLC) was used to achieve separation on a C18 column and mobile phase of ethanol and 0.1% orthophosphoric acid in water under isocratic conditions at a 1.0 mL/min flow rate. Results: These two approaches were confirmed in accordance with the International Council for Harmonisation Q2(R1). The tools used to measure environmental sustainability were the analytical Eco-Scale, AGREE, Complex Gapi, and NEMI. These UV techniques were linear over the concentration ranges of 4–20 μg/mL of azelnidipine and 5–25 μg/mL of metoprolol succinate. The RP-HPLC technique displayed linearity between 16 and 80 μg/ mL of azelnidipine and 25–125 μg/mL of metoprolol succinate. Conclusion: Both techniques proved to have acceptable precision, accuracy, sensitivity, and assay values. Both techniques were found to be environmentally friendly by a green assessment.