An environmental green factorial design/assisted spectrofluorimetric technique for quantitation of citicoline in pharmaceutical dosage form and wastewater

Abstract

Abstract A novel, sensitive, and straightforward spectrofluorimetric method was developed for the quantitative determination of citicoline in pharmaceutical formulations and wastewater. The technique depends on the efficient derivatisation of the primary amino group of citicoline with O-phthalaldehyde (OPA) and N-acetylcysteine (NAC) in borate buffer (pH 11), yielding a highly fluorescent derivative. The fluorescence intensity was measured at 425 nm with an excitation wavelength of 341 nm. Experimental parameters affecting the derivatisation reaction were thoroughly optimised. Under optimal conditions, the method exhibited a linear response over the concentration range of 50.0–300.0 ng/mL, with an excellent correlation coefficient (R2 = 0.9942). The limits of detection (LOD) and quantification (LOQ) were 6.4 ng/mL and 19.5 ng/mL, respectively. The approach demonstrated high accuracy and precision, with per cent recovery values close to 100% and a relative standard deviation (RSD) of 0.512%, confirming its reliability. Validation was done in agreement with ICH Q2(R1) guidelines, and statistical comparison with previously reported approaches indicated no significant difference in performance. The sustainability of the method was studied using the analytical greenness tools confirms the method’s eco-friendly profile. Collectively, these contributions advance drug bioavailability while promoting a more efficient and sustainable analytical framework.