METHOD DEVELOPMENT AND VALIDATION OF MESALAMINE IN PHARMACEUTICAL DOSAGE FORM: A REVIEW

Abstract

Anti-inflammatory agents are the important class of drugs used in various commercial pharmaceutical formulations for the treatment of fever, inflammation and minor pain. One of the important anti-inflammatory drug is Mesalamine which belongs to the class of Amino-salicylic acid derivatives. Mesalamine is a bowel specific anti-inflammatory drug used in the treatment of inflammatory bowel diseases such as ulcerative colitis and Crohn’s disease.it is available in different pharmaceutical dosage forms such as delayed release, extend release and enteric coated tablets and capsulesetc., The several of Mesalamine brand’s available in market are Apriso, Asacol MR-400mg, Lialda, Pentasa-500mg, Asalosa- 800 etc. Hence routine quality control of Mesalamine in these pharmaceutical dosage forms requires effective analytical procedures. In this present review an extensive survey of research work published in various research journals has reviewed and found that various instrumental analytical methods were developed, validated and used for the estimation of Mesalamine in bulk drug and formulation. The developed analytical methods include Spectrometric such as Ultraviolet (UV) and Visible; Spectroflourimetric and Chromatographic methods such as High Performance Liquid Chromatographic (HPLC), Reverse Phase High Performance Liquid Chromatographic (RP-HPLC), Ultra Performance Liquid Chromatographic (UPLC) Keywords: HPLC, Mesalamine, Anti-inflammatory, Method Development