Novel Spectrofluorimetric Techniques for Cerebrolysin Quantification and First Derivative Synchronous Fluorescence Analysis of Cerebrolysin and Donepezil in Human Plasma and Dosage Forms With Content Uniformity and Comprehensive Green Analytical Assessment

Abstract

ABSTRACT Cerebrolysin and donepezil are frequently co‐administered for the management of Alzheimer disease. This research established innovative, efficient, and inexpensive spectrofluorimetric methods to quantify cerebrolysin and donepezil. Method I utilized first derivative synchronous fluorometry for the first time to simultaneously estimate CRB and donepezil (DNP) at 325 and 350 nm, respectively, with a Δλ of 40 nm. A rectilinear correlation between concentration and response was observed across 2.00–20.0 μg/mL and 0.03–1.00 μg/mL for CRB and DNP, respectively. The method demonstrated notable sensitivity, with quantitation and detection limits of 0.72 and 0.013 μg/mL, and 0.24 and 0.004 μg/mL, for CRB and DNP, respectively. Method II describes a spectrofluorometric method for measuring the native fluorescence of CRB in water at 277/345 nm across the range of 1.00–10.0 μg/mL with detection and quantitation limits of 0.69 and 0.23 μg/mL, respectively. These methodologies were effectively applied to various dosage forms with satisfactory percentage recoveries. They were further successfully applied to spiked human plasma samples, proving their applicability to therapeutic drug monitoring for inpatients. Additionally, the environmental impact of these methods was assessed using four different greenness criteria.