The present study aimed to develop and validate a simple, precise, accurate, and cost- effective colorimetric analytical method for the quantitative estimation of mesalamine in accordance with ICH guidelines. The proposed method is based on the formation of a stable colored complex, which was analysed using UV–Visible spectrophotometry. Mesalamine exhibited a well-defined absorption maximum at 558.4 nm, indicating suitability for spectrophotometric measurement. The method showed good linearity over the concentration range of 10–50 µg/mL, with a correlation coefficient (r²) of 0.9973, demonstrating excellent linear regression characteristics. The developed method was validated for analytical performance parameters and found to be reliable and reproducible. Owing to its simplicity, sensitivity, and accuracy, the method can be effectively applied for routine analysis of mesalamine in bulk drug and pharmaceutical dosage forms.
K. et al. (Fri,) studied this question.