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Teriflunomide Quantitative Assessment in Pharmaceutical Tablet Formulations and Bulk Using a Validated UV-Visible Spectrophotometric Method


Authors : K. Ramani; K. Manogna; C. Divya; T. Akshitha; Srinivas Chinta

Volume/Issue : Volume 11 - 2026, Issue 9 - September


Google Scholar : https://tinyurl.com/2zaufufm

DOI : https://doi.org/10.38124/ijisrt/26sep021

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Abstract : A simple, rapid, accurate, precise and economical UV–Visible spectrophotometric method was developed and validated for the quantitative estimation of teriflunomide, an immunomodulatory agent, in bulk active pharmaceutical ingredient and finished dosage form. Teriflunomide showed maximum absorbance at 245 nm in methanol, which was selected as the analytical wavelength. The approach was assessed, for linearity, accuracy, precision, robustness, ruggedness, limit of detection (LOD) and limit of quantification (LOQ) in accordance with the validation principles described in ICH Q2(R1).

Keywords : Teriflunomide; UV–Visible Spectroscopy; Analytical Method Validation; Linearity; Accuracy; Precision; Assay; Pharmaceutical Analysis.

References :

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  7. Boltia, S. A., Mora, M. M., Ismail, N. S., & Zaazaa, H. E. (2024). Validated chromatographic methods for determination of teriflunomide and investigation of its intrinsic stability. BMC chemistry18(1), 93.
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A simple, rapid, accurate, precise and economical UV–Visible spectrophotometric method was developed and validated for the quantitative estimation of teriflunomide, an immunomodulatory agent, in bulk active pharmaceutical ingredient and finished dosage form. Teriflunomide showed maximum absorbance at 245 nm in methanol, which was selected as the analytical wavelength. The approach was assessed, for linearity, accuracy, precision, robustness, ruggedness, limit of detection (LOD) and limit of quantification (LOQ) in accordance with the validation principles described in ICH Q2(R1).

Keywords : Teriflunomide; UV–Visible Spectroscopy; Analytical Method Validation; Linearity; Accuracy; Precision; Assay; Pharmaceutical Analysis.

Paper Submission Last Date
30 - September - 2026

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