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

Shubhamkar Ashok Desai,Prof R.N Kale

doi:10.32553/ijpba.v7i3.130

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

Highlights

Mesalamine known as mesalazine or 5-amino salicylic acid (5-ASA), is an anti-inflammatory drug used to treat inflammatory bowel disease, such as ulcerative colitis and mild-tomoderate Crohn’s disease
The absorbance value at 303nm was used for the estimation of Mesalamine and obeyed Beer’s law in the concentration range of 10- 50μg/ml [4]
B was based upon the reaction of Mesalamine with Folin ciocalteu phenol’s reagent under alkaline condition forming blue colored chromogens which shows absorption maxima at 725nm and obeyed Beer’s law concentration range within 4- 24μg/ml [12]

Summary

Introduction

Mesalamine known as mesalazine or 5-amino salicylic acid (5-ASA), is an anti-inflammatory drug used to treat inflammatory bowel disease, such as ulcerative colitis and mild-tomoderate Crohn’s disease. Moharana AK et al, have reported a simple and cost effective spectrophotometric method for the estimation of Mesalamine in pure form and in pharmaceutical formulations. Rao RN et al, have developed and validated an UV Spectrophotometric method for the determination of Mesalazine in pure and tablet dosage form.

Results

Conclusion