Stability Indicating HPTLC Method for Determination of Mesalamine

Author(s): Mrinalini C. Damle* and Anand M. Singhal

Abstract: Mesalamine is an anti-inflammatory agent used for treating ulcerative colitis and mild to moderate Crohn’s disease. It is used clinically for the treatment of conditions such as diarrhea, rectal bleeding and stomach pain. It belongs to class of drugs known as amino salicylates. It is available in the market as granules, tablets, capsule, rectal suspensions, enema and suppositories in different strengths. A simple, rapid validated stability indicating HPTLC method for Mesalamine has been successfully developed. This method is based on HPTLC separation followed by UV detection at227nm. The separation was carried on Merck TLC aluminium sheets pre-coated with Silica Gel 60F254 using Ethyl acetate: Methanol: Ammonia as a Mobile Phase. Mesalamine gave well defined and sharp peak at Rf0.40± 0.02. Calibration curve was linear in range 250-1250ng/band. Stress degradation was carried out as per ICH Q1A(R2). The study included hydrolysis at different pH, oxidation, thermal and photolytic stress conditions. This method can be applied to determination of stability of Mesalamine. The suitability of this HPTLC method for quantitative determination of Mesalamine was proved by validation in accordance with requirements of ICH guidelines Q2A(R1).

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