A Safranin Dye-Based Luminescent 'Signal-On' Complex for Highly Sensitive Detection of Memantine Hydrochloride in Tablets and Human Plasma

Authors

1 Department of Pharmaceutical Chemistry, Faculty of Pharmacy, AlSalam University, Egypt

2 Pharmaceutical Analysis Department, Faculty of Pharmacy, Menoufia University, Egypt.

3 Pharmaceutical Analysis Department, Faculty of Pharmacy, Menoufia University, Egypt

Abstract

Abstract
A novel, rapid , accurate, and sensitive spectrofluorimetric assay for detecting memantine hydrochloride (Mem-HCl) a none chromophoric drug utilized for treatment of Alzheimer's disease was developed. This method relies on the complexation of Mem-HCl with safranin, forming a highly fluorescent complex. The developed complex was extracted using chloroform under the optimized conditions, and the fluorescence intensity was measured at 549 nm following excitation at 520 nm. The assay effectively measured memantine hydrochloride concentrations in the range of 3.00-50.00 μg/ml with good accuracy, with detection and quantification limits of 0.86 and 2.61 μg/ml, respectively. The method was validated according to International Council for Harmonization (ICH) guidelines and was successfully applied to analyze Mem-HCl in both pharmaceutical dosage forms and spiked human plasma samples, showcasing its potential for use in clinical and quality control laboratories. The proposed assay offers a high degree of sensitivity, making it an excellent alternative for the routine analysis of Mem-HCl in various applications, including therapeutic monitoring and quality assurance in pharmaceutical formulations. This technique is efficient, cost-effective, and well-suited for routine clinical and industrial use.

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