Efficient UV-Visible spectrophotometric method for quantitative estimation of mesalamine in pharmaceutical formulations
DOI:
https://doi.org/10.12923/cipms-2026-0016Keywords:
mesalamine quantification, UV-visible spectrophotometry, BCS Class IV drug, analytical validationAbstract
Mesalamine, a Biopharmaceutics Classification System (BCS) Class IV drug, exhibits poor solubility and low permeability, posing considerable challenges for accurate quantification. The aim of this study was to develop and validate a robust, cost-effective, and environmentally sustainable UV-visible spectrophotometric method for the precise quantification of mesalamine in ethanol and phosphate-buffered saline (PBS, pH 7.4), in accordance with International Council for Harmonisation (ICH) Q2(R1) guidelines. The method was optimized at a maximum absorption wavelength of 300 nm and validated with respect to linearity, accuracy, precision, specificity, and sensitivity through the determination of the limits of detection (LOD) and quantification (LOQ). Calibration curves were constructed over a concentration range of 10–100 µg/mL. The proposed method demonstrated excellent linearity, with a correlation coefficient (R²) of 0.99. Relative standard deviation (%RSD) values remained below 0.5%, indicating good repeatability and reproducibility. Accuracy was confirmed by recovery values ranging from 99.3% to 101.9%. The calculated LOD and LOQ values for mesalamine in ethanol (10.0 and 21.1 µg/mL, respectively) and PBS (6.8 and 20.6 µg/mL, respectively) were within acceptable limits according to ICH recommendations, confirming the sensitivity and reliability of the analytical method. The validated UV-visible spectrophotometric method provides a rapid, reliable, and cost-effective approach for the routine quantification of mesalamine during formulation development and pharmaceutical quality control. Owing to its simplicity and resource-efficient nature, the method represents a practical alternative to more complex chromatographic techniques. Further studies may broaden its applicability through integration with advanced analytical approaches in pharmaceutical sciences.
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