ArticleBMC chemistry2025
Design and validation of a robust stability-indicating reversed-phase HPLC method for quantification of mesalamine in formulated drug products.
Article in BMC chemistry, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
A reliable and sensitive RP-HPLC method was developed and validated for the accurate quantification of mesalamine in bulk and formulated pharmaceutical products. The analysis was carried out on a C18 column (150 mm × 4.6 mm, 5 μm) using a mobile phase of methanol: water (60:40 v/v), with a flow rate of 0.8 mL/min, and UV detection at 230 nm. Methanol: water (50:50 v/v) was used as the diluent. The method demonstrated excellent linearity across the concentration range of 10-50 µg/mL (y = 173.53x - 2435.64, R² = 0.9992), high accuracy with recoveries between 99.05% and 99.25% (%RSD < 0.32%), and outstanding precision with intra- and inter-day %RSD values below 1%. Robustness was confirmed under slight method variations (%RSD < 2%), and LOD and LOQ were found to be 0.22 µg/mL and 0.68 µg/mL, respectively. Forced degradation studies under acidic, basic, oxidative, thermal, and photolytic stress confirmed the method's specificity and stability-indicating capability. Assay of a commercial mesalamine tablet (Mesacol
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