New Analytical Method Development and Validation of UV -visible Spectroscopy for the Estimation of Sulpiride: A Narrative Review

Abstract

The aim is to develop novel analytical methods, and validation is a continuous and interdependent task associated with the research and development, quality control, and quality assurance departments. Analytical procedures play a crucial role in assessing and managing equivalence risk. It helps establish product-specific acceptance criteria and the stability of results. Validations determine that the analytical procedure is suitable for its intended purpose. The literature survey reveals that analytical methods are based on UV-Visible spectrophotometry for determining Sulpiride Bulk and in combination with different drugs, as well as the study of Chemical characteristics using FTIR Spectra. The parameters were validated according to ICH guidelines in terms of Accuracy, Precision, Robustness, Ruggedness, and other components of analytical validation. The developed methods are simple, sensitive, and reproducible, and can be used for the analysis of sulpiride in bulk and Tablet dosage forms. FTIR analysis reveals the presence of Various functional groups and the structure of sulpiride. Those Functional groups are essential for therapeutic and biomechanical applications as antipsychotic drugs.