A Novel Sustainable UV Spectrophotometric Approach for the Quantification of Amisulpride in Bulk and Nanoformulations

Background: Schizophrenia is a persistent neuropsychiatric condition that requires precise drug delivery to the brain for effective treatment. Amisulpride, a second-generation antipsychotic, has low oral bioavailability and struggles to cross the blood–brain barrier, thus requiring innovative formulation techniques and dependable analytical methods. The aim of the proposed research work was to develop and validate an eco-friendly UV spectroscopy for measuring amisulpride in bulk drugs, niosomal formulations, and commercial products, promoting sustainable pharmaceutical quality control. Materials and Methods: A UV spectrophotometric approach was developed using a methanol: water (77:23) solvent mixture, with detection at 280 nm. Validation followed ICH Q2 (R1) guidelines, evaluating linearity, precision, accuracy, robustness, ruggedness, LOD, and LOQ. Amisulpride-loaded niosomes were formulated by the ethanol injection method using Span-60 and cholesterol. Particle size and Zeta potential were analyzed by Malvern Zetasizer. Results: The method showed excellent linearity (r² = 0.998), precision (%RSD < 2%), and recovery rates (97–101.3%). LOD and LOQ were found to be 0.58 μg/mL and 1.2 μg/ mL, respectively. Niosomes had a particle size of 200.89 nm and a zeta potential of –23.6 mV. This method effectively detected amisulpride in the various formulations. Conclusion: The validated UV method provides a precise, robust, and sustainable alternative to chromatographic techniques, facilitating the routine quality evaluation of amisulpride in advanced nanoformulations.