ABSTRACT

According to the current study, a novel methodology should be developed and tested in order to ascertain the bulk and formulation concentrations of silodosin. This analytical method can be described as sensitive, exact, fast. Utilising a multivariate calibration process and a UV spectrophotometer, the analytical approach was conducted. We utilized the established relationship between concentration and absorbance at five distinct wavelengths, including the absorption maxima at 269 nm, to construct this multivariate calibration approach. The linear regression equations were employed in conjunction with other mathematical and statistical methods to validate the process in accordance with the ICH Q2 (R1) requirements. The instructions' validation parameters for linearity, precision, and other factors have all been met. This technology is dependable, sensitive, and economical when used to routine drug and formulation examinations. The analytical, Agree metrics, Eco scale and Green Analytical Procedure Index were used to calculate the technique greenness values. Keywords: Silodosin, Multivariate calibration technique, UV spectrophotometric, Pharmaceutical formulations, ICH guidelines, Validation
Publication date: 01/11/2025

https://ijbpas.com/pdf/2025/November/MS_IJBPAS_2025_9585.pdf

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https://doi.org/10.31032/IJBPAS/2025/14.11.9585