QbD stability-indicating UPLC method for quantification of teriflunomide and its impurities

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The UPLC method was developed based on QbD concepts for rapid quantification of teriflunomide in pharmaceutical drug products. The developed method was validated as per ICH guidelines. The method was found to be simple, selective, accurate, precise, and robust. The developed method was stability indicating as it was showing no interference of degradation products and placebo at the retention time of teriflunomide. Due to the shorter run time of 1 min, this method provides faster analysis, more work throughput, and reduces the cost of analysis due to the reduction in solvent consumption. The method can be used for in-vitro dissolution analysis. Therefore, the developed method can be used for routine assay and in-vitro dissolution analysis of quality control samples and stability samples of bulk and finished pharmaceutical dosage form.

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