Abstract

DEVELOPMENT AND VALIDATION OF A UV-VISIBLE SPECTROPHOTOMETRIC METHOD FOR RILUZOLE USING ANALYTICAL QUALITY BY DESIGN APPROACH

Sanket B. Raikwade*, Dr. Chetan Jain, Ms. Mayuri Ban

Abstract

An Analytic Quality by Designs (AQbD's) strategy was used to create and validate a quick, easy, economical, & environmentally friendly UV-visible spectrophotometric technique for the measurement of Riluzole. Design of Experiments (DoE) was used in the method development process utilizig Design Expert® software 13.0 to investigate the impact of important method variables on absorbance, such as solvent type and analysis speed. Ethanol was selected as the optimum solvent based on maximum absorbance and green chemistry considerations. Riluzole showed maximum absorbance (λmax) at 222 nm. The results showed that solvent type had a substantial impact on absorbance using a twofactors, two-levels factorial designs, whereas speed of analysis showed no significant influence. The ICH Q2(R1) recommendations were followed in the validation of the optimised method. With a strong correlation coefficient, the technique showed good linearity in the concentration range of 2–10 μg/ml. Precision studies showed the method's intermediate precision and repeatability with %RSD values below 2%. Recovery studies confirmed accuracy with mean recoveries between 98–102%. The method was found to be robust and rugged with minimal variation in absorbance. The results showed that the LOD and LOQ were 0.5657 μg/ml and 1.7143 μg/ml, respectively. For periodic quality control evaluation of Riluzole in pharmaceutical products, the established approach is straightforward, dependable, eco-friendly, and appropriate.

Keywords: UV-Visible Spectroscopy, QbD, Method development, Validation, Design Expert 13.0, Riluzole.