Spectrophotometric Method for Simultaneous Estimation of Mesalamine and Prednisolone in Combined Oral Dosage Form

The objective of this study was to develop simple, precise, accurate, reproducible and economical vireodt's method for simultaneous estimation of mesalamine (MSM) and prednisolone (PRD) in combined oral dosage form. The method involved measurement of absorbance at two wavelengths, 332nm and 246nm, λmax of MSM and PRD, respectively in phosphate buffer (pH 7.4) with dimethyl formamide (DMF) as cosolvent. The linearity was obtained in the concentration range of 5-50 μg/ml and 2-20 μg/ml for MSM and PRD, respectively. The average percent recovery of MSM and PRD was found to be 99.19+0.78% and 99.71+0.82%, respectively. The accuracy and precision were determined and recovery studies confirmed the accuracy of the developed method that was carried out following the International Conference on Harmonization (ICH) guidelines. The recovery study was carried out by standard addition method. The proposed method was found to be rapid, specific, precise, accurate, and reproducible and can be successfully applied for the routine analysis of MSM and PRD in pharmaceutical dosage form. INTRODUCTION: Mesalamine (MSM) (Figure 1) is chemically (5–amino–2–hydroxy benzoic acid), is an anti-inflammatory drug used to treat inflammation of the digestive tract (crohn’s disease) 1, 2 and mild to moderate ulcerative colitis . It is a bowl-specific amino salicylate drug that is metabolized in the gut and has its predominant actions there, thereby having fewer systemic side effects . FIGURE 1: CHEMICAL STRUCTURE OF MESALAMINE (MSM) Prednisolone (PRD) (Figure 2) is chemically (11β)-11, 17, 21 trihydroxypregna-1, 4-diene-3, 20-dione), is a typical glucocorticoid has been used for the treatment of ulcerative colitis as the second line drug in the therapy 5, . It has predominant glucocorticoid and low mineral corticoid activity and used for the treatment of a wide range of inflammatory and auto-immune diseases . FIGURE 2: CHEMICAL STRUCTURE OF PREDNISOLONE (PRD) Correspondence to Author: