Gentisic acid

Application description

This HPLC method presents the analysis of 5-Aminosalicylic acid (Mesalamine) and related impurities in Mesalamine using an Amaze RP SA mixed-mode column. The method includes a detailed characterization of the main compound and its impurities, ensuring accurate quantification. Mesalamine, also known as 5-aminosalicylic acid (5-ASA), is a medication primarily used to treat inflammatory bowel diseases such as ulcerative colitis and Crohn's disease. It is a derivative of aminosalicylic acid and possesses anti-inflammatory properties. Gentisic acid, also known as 2,5-dihydroxybenzoic acid, is a metabolite of salicylic acid. It is a derivative of benzoic acid and is commonly found in various plants and fruits. Gentisic acid exhibits antioxidant properties and is soluble in both water and organic solvents. 3-Aminosalicylic acid, also known as PAS (para-aminosalicylic acid), is an antimycobacterial and an impurity in mesalamine. It is structurally similar to mesalamine but contains an amino group at the para position of the benzene ring. Salicylic acid is a naturally occurring compound found in plants and is a precursor to aspirin. It possesses anti-inflammatory and keratolytic properties. Salicylic acid is an impurity in mesalamine. These compounds, including mesalamine and its impurities gentisic acid, 3-aminosalicylic acid, and salicylic acid, exhibit varying degrees of water solubility and polarity, which influence their behavior during chromatographic separation. Effective separation techniques are crucial for accurately quantifying these compounds in pharmaceutical formulations and ensuring product quality and efficacy. Amaze RP SA column is exploring small differences in hydrophobic and ionic properties to achieve baseline separation of mesalamine and related impurities. The Amaze RP SA mixed-mode column is chosen for its unique selectivity, combining reversed-phase and strong cation-exchange and anion-exclusion properties. This mixed-mode stationary phase offers versatile separation capabilities, allowing for efficient retention and resolution of both the main compound and impurities. The reversed-phase component facilitates separation based on hydrophobic interactions, while the cation-exchange and anion-exclusion component enables selectivity for charged species.