Reversed-Phase High Performance Liquid Chromatographic Determination of Rifampin in the Presence of Its Acid-Induced Degradation Products

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Abstract
The determination of rifampin in the presence of its acidinduced degradation products by reversed-phase high performance liquid chromatography is described. The method was validated as stability-indicating by forced decomposition of rifampin in acid media. Chromatographic conditions included a Nova-Pak® C18 (3.9 x 150 mm, 5 μm) column and a mobile phase consisting of 0.02M Na2HPO4 and acetonitrile (65:35 v/v), apparent pH 4.5 ± 0.2 adjusted by the addition of phosphoric acid. All analyses were done under isocratic conditions at a flow rate of 1 mL/min and at room temperature. The recovery average was 99.39% for rifampin. The method was applied to determine rifampin in commercial capsules and compared with the official method of the USP XXIII with good agreement between the results.