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Development and validation of gradient stability indicating HPLC method for determining Ezogabine and related substances

M.Balaji, K.M.Ch.Appa Rao, K.Ramakrishna, V.Srinivasarao

A high performance liquid chromatographic method is presented for the determination of Ezogabine and its impurities in the presence of its degradation products using a reverse phase C18 column at ambient temperature with mobile consisting of 0.01Mdi potassiumhydrogen phosphate pH 7.6 and acetonitrile. The flowrate was 0.8ml/min. Quantitation was achieved with wavelength at 254nm. The proposed method was validated for specificity, linearity, accuracy, LOD, LOQ, precision and robustness. The method was found to be suitable for the quality control of Ezogabine in bulk drug and dosage form as well as the stability indicating.