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Development of a validated RP-HPLC assay method for quantitative separation of Teriflunomide and its process-related impurities in bulk drugs

Bhagavan Rajesh Babu Koppisetty, Rajendra Prasad Yejella, A. Krishna Manjari Pawar, Srinivasa Rao Yarraguntla, Varaprasada Rao Kollabathula, Vasudha Dadi, Challa Gangu Naidu.

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The organic, inorganic, and residual solvent impurity sources in pharmacological compounds have been divided into categories by the International Council for Harmonization. The pharmaceutical sector faces a regulatory hurdle since the organic contaminants could be genotoxins. The detection and method development also a validation of organic contaminants produced during the chromatographic separation of a teriflunomide is the main goal of this work. The impurity profile research was carried out using a diode array detector and reverse phase-high performance liquid chromatography. At a column temperature of 25°C, the C18 YMC-Pack ODS column was successfully achieved through gradient separation. As the mobile phase, acetonitrile and 0.015 M potassium dihydrogen phosphate with a pH of 3.5 were employed. A 210 nm detector wavelength and 1.0 ml/minute flow rate were adopted. Six process-related impurities were successfully separated using the validated analytical method, with resolution and retention times under 35 minutes. Teriflunomide, Teriflunomide stage-1, and Impurity-D have established analytical techniques with ranges of 0.066–3.262, 0.035–1.880, and 0.025–1.255 μg/ml, respectively. Teriflunomide, Teriflunomide stage-1, and impurity-D have respective limits of detection and limit of quantification values of 0.0037 and 0.0096, 0.0016 and 0.0051, and 0.0011 and 0.0033 μg/ml. The confirmed analytical approach can effectively identify any manufacturing process impurities.

Key words: Related Impurities, RP-HPLC, Teriflunomide, Method development

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