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Development of spectrophotometric method for determination of mesalazine in pharmaceutical preparation

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The molar absorptivities were 1.5.104 l.mol-1 .cm-1 and Sandell's sensitivity index of 0.0263 μg.cm-2 . Recoveries of mesalazine from excipients were 95.4 -102.3 %. No interference was observed from common excipients present in pharmaceutical formulations. The proposed method has been applied successfully to determine mesalazine in pharmaceutical preparation as tablets (Pentasa and Sunmesacol). | Vietnam Journal of Chemistry, International Edition, 54(4): 509-514, 2016 DOI: 10.15625/0866-7144.2016-00356 Development of spectrophotometric method for determination of mesalazine in pharmaceutical preparation Nguyen Trung Dung*, Nguyen Thi Lan Anh, Dong Thi Oanh, Nguyen Hoang Dung Faculty of Physics and chemical Engineering, Le Quy Don Technical University Received 18 May 2016; Accepted for publication 12 August 2016 Abstract A simple, rapid, sensitive and accurate spectrophotometric method for the determination of mesalazine in pharmaceutical preparation has been developed. The method is based on the reaction of mesalizine, with excessive nitrite, in an acidic medium, to produce the corresponding diazonium salt. After the removal of residual nitrite with sulphamic acid, the diazonium salt was coupled with N-(1-naphthyl)ethylenediamine (NEDA) in acidic medium to give a violet colored azo dye which has maximum absorption at 552 nm, the colored chromogen was stable for twenty four hours. Beer's law is obeyed in the concentration range of 0.5-40.0 µg/ml (R2 = 0.999) with limit of detection (LOD) being 0.113 µg/ml. The molar absorptivities were 1.5.10 4 l.mol-1.cm-1 and Sandell's sensitivity index of 0.0263 μg.cm-2. Recoveries of mesalazine from excipients were 95.4 -102.3 %. No interference was observed from common excipients present in pharmaceutical formulations. The proposed method has been applied successfully to determine mesalazine in pharmaceutical preparation as tablets (Pentasa and Sunmesacol). Keywords. Mesalazine, spectrophotometry, NEDA, Bratton-Marshall reagent, Pharmaceutical Preparation. 1. INTRODUCTION Mesalazine (mesalamine, 5-aminosalicylic acid, 5-ASA) is used to treat inflammatory bowel diseases, especially non-specific ulcerative colitis and Crohn’s disease. Drugs based on both mesalazine parent substance and its prodrugs (sulfasalazine, olsalazine, balsalazide) are often used for this. Mesalazine is metabolized in vivo .

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