ABSTRACT

The primary aim of this study is to develop and verify a simple, reliable, precise, and convenient UV- visible spectroscopic method for determining the quantity of Itopride hydrochloride, following the recommendations outlined in ICH Q2 (R1). The multivariate calibration uses linear regression analysis to determine the relationship between absorbance and concentration at five evenly dispersed wavelengths. Using water as the solvent, Itopride hydrochloride displayed ????max at 258 nm. A linear plot was obtained with a regression coefficient of 0.9993 for the concentrations between 15-45 ?g mL-1. The % RSD for intra-day and inter-day precision were found to be 0.157 and 0.194, respectively. The assay was determined and found to be 100.10 % w/w. Keywords: Itopride hydrochloride, UV-visible spectrophotometry, Multivariate calibration, ICH guidelines
Publication date: 01/11/2025

https://ijbpas.com/pdf/2025/November/MS_IJBPAS_2025_9554.pdf

Download PDF
https://doi.org/10.31032/IJBPAS/2025/14.11.9554