Comprehensive Quantitative Nmr Analysis of Galantamine

Abstract Galantamine is a clinically important Amaryllidaceae alkaloid commonly used in the treatment of Alzheimer’s disease, where accurate structural confirmation and purity determination are critical due to its narrow therapeutic index. Conventional chromatographic methods used for galantamine analysis often require extensive calibration, reference standards, and complex sample preparation, which may limit analytical efficiency and traceability. In the present study, a comprehensive nuclear magnetic resonance (NMR) based analytical strategy was developed for both structural elucidation and quantitative determination of galantamine. Complete structural confirmation was achieved using one-dimensional (¹H, ¹³C, and DEPT) and two-dimensional (HSQC, HMBC, and COSY) NMR techniques. Quantitative analysis was performed using quantitative ¹H NMR (qNMR) with imidazole as an internal standard. The developed qNMR method exhibited excellent linearity over the concentration range of 0.5–3.0 mg/mL (R² > 0.997), high accuracy with recoveries between 97–100%, and good intra- and inter-day precision (%RSD < 1%). Robustness studies demonstrated that minor variations in acquisition parameters had no significant impact on quantification. The combined qualitative and quantitative NMR results confirm the structural integrity, chemical purity, and analytical reliability of galantamine. This study highlights qNMR as a non-destructive, reproducible, and traceable analytical platform suitable for routine pharmaceutical quality control, and regulatory applications of galantamine and related alkaloids.