Synthesis and Characterization of Metabolites and Potential Impurities of Balsalazide Disodium,an Anti-Inflammatory Drug |
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| Authors: | Md. Umar Khan M. A. Baseer S. Ranjith Kumar M. Saravanakumar A. G. Prasannanjali P. Badarinadh Gupta |
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| Affiliation: | 1. Chemical Research and Development Department , APL Research Centre, Aurobindo Pharma Ltd. , Hyderabad, India;2. Organic Chemistry Research Laboratory, Yeshwant Mahavidyalaya , Nanded, India;3. Organic Chemistry Research Laboratory, Yeshwant Mahavidyalaya , Nanded, India;4. Chemical Research and Development Department , APL Research Centre, Aurobindo Pharma Ltd. , Hyderabad, India |
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| Abstract: | Balsalazide disodium (Colazide®) is an oral prodrug of mesalamine (5-aminosalicylic acid) and possesses anti-inflammatory properties. During the process development for balsalazide disodium, we observed eight impurities, namely des-β-alanine balsalazide, balsalazide β-alanine, balsalazide 3-isomer, decarboxy balsalazide, bis-azo salicylic acid, biphenyl-azo salicylic acid, bis-azo diacid, and bis-azo triacid. The present work describes the synthesis and characterization of these impurities. |
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| Keywords: | 5-Aminosalicylic acid balsalazide diazo coupling impurities synthesis |
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