Eco-friendly second derivative synchronous fluorescence spectroscopic method for simultaneous determination of rosuvastatin and ezetimibe in pharmaceutical capsules

Abstract

The fixed dose combination of Rosuvastatin and ezetimibe has recently received approval from the FDA for the treatment of elevated levels of low-density lipoprotein cholesterol in adults. Herein, an eco-friendly and highly sensitive spectrofluorimetric method was developed and validated for simultaneous determination of rosuvastatin and ezetimibe in commercial capsules. The developed method involved synchronous fluorescence spectroscopy combined with second derivative spectroscopy to resolve the overlapping fluorescence spectra of rosuvastatin and ezetimibe. The studied drugs were measured in synchronous mode at Δλ of 40 and their recorded synchronous fluorescence spectra were derivatized into second-order spectra, enabling the selective quantification of rosuvastatin and ezetimibe at 370 nm and 312 nm, respectively. Optimization studies regarding to the influence of buffer pH, incorporation of surfactant, choice of diluting solvent, and synchronous Δλ were carried out. The method was validated using the validation characteristics listed in ICH Q2(R1). The calibration curves displayed satisfactory linear relationships across the calibration range of 0.1–2 µg/mL for rosuvastatin and 0.05–3 µg/mL for ezetimibe. The methodology demonstrated robustness to minor modifications in the procedural parameters and selectivity in quantifying the studied drugs in synthetic mixed solutions and commercial capsules without interference. Furthermore, the level of environmental friendliness and sustainability of the suggested spectrofluorimetric approach was assessed in relation to two previously documented methodologies utilizing the AGREE metric. The findings indicated that the suggested method demonstrated a notably superior level of sustainability in comparison to the documented methods.