Eco-friendly and stability-indicating HPTLC method for the estimation of Carvedilol in pharmaceutical dosage forms: A greenness assessment using NEMI scale, AGREE, and White Analytical Chemistry

Abstract

A robust, sensitive, and ecofriendly stability-indicating HPTLC method was developed for the quantification of carvedilol (Coreg tablets) and validated. The method was optimized to avoid carcinogenic solvents, employing a mobile phase of toluene, isopropanol, ammonia (7.5:2.5:0.1, v/v/v), ensuring sharp and symmetric peaks with minimal tailing. The separation was attained on a silica gel 60F254 TLC plate, using ascending development up to 75 mm at room temperature. The developed method demonstrated excellent linearity in the range of 20–120 ng/band with a R² value 0.995. Forced degradation studies revealed the effective separation of carvedilol (Coreg tablets) and degradant, with an Rf value of 0.44 ± 0.02 for the parent compound. Carvedilol (Coreg tablets) was found to be stable under neutral, photolytic, and thermal conditions, while significant degradation was observed under acidic, alkaline, and oxidative stress conditions. The proposed method was useful to the assay of three brands of carvedilol (Coreg tablets) tablets, yielding results between 99 % and 101 % of the labelled claim. Greenness assessment using NEMI scale, AGREE software, Eco scale assessment, GAPI and white analytical chemistry highlighted the method's environmental benefits, surpassing published chromatographic methods. The simplicity, accuracy, and eco-friendly nature of the developed method make it an ideal choice for tedious quality control and stability studies of carvedilol (Coreg tablets).