Spectrophotometric Determination of Mesalazine in Pure Form and Pharmaceutical Formulations by Diazotization and Coupling With 2,7-Dihydroxynaphthalene As a New Coupling Agent

Abstract

A simple, specific and sensitive spectrophotometric method is presented for the determination of Mesalazine (MZN) based on diazotization in an acidic medium through reaction with sodium nitrite (NaNO2) to form a diazonium salt that coupling reaction in a base medium with 2,7-Dihydroxynaphthalene (DHNP) to form an azo dye. The dye intensity was measured at 501 nm after optimization of the experimental parameters. Beer’s law was applied to the proposed method, valid within a concentration range of 0.25–10 μg.mL-1, and the linear regression was R2 = 0.9974. The limit of detection (LOD), the limit of quantification (LOQ), the molar absorptivity coefficient were 0.074 μg.mL-1,0.249 μg.mL-1 and 1.85x104 L.mol−1.cm−1, respectively. Sandell's sensitivity was 0.0082μg.cm-2. There is no interference from excipients found in the tablet. The data were statistically compared with the British Pharmacopeia using two statistical methods (t-test and F-test).

Keywords

• mesalazine (MZN)
• 2,7-Dihydroxynaphthalene (DHNP)
• Diazotization
• Coupling Reaction

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