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 :
- Chan, A., de Seze, J., & Comabella, M. (2016). Teriflunomide in patients with relapsing–remitting forms of multiple sclerosis. CNS drugs, 30(1), 41-51..
- Guideline, I. H. T. (2005). Validation of analytical procedures: text and methodology. Q2 (R1), 1(20), 05..
- Allen, R. J. (1976). Manual of Psychiatric Therapeutics: Practical Psychopharmacology and Psychiatry.
- Skoog, D. A., Holler, F. J., & Crouch, S. R. (1998). Principles of instrumental analysis (Vol. 849). Philadelphia: Saunders college publishing.
- Kashid, A. M., Polshettiwar, P. P., & Bhosale, K. M. (2022). Analytical method development and validation of teriflunomide active pharmaceutical ingredient by RP-UHPLC. Asian Journal of Pharmaceutical Analysis, 12(3), 166-2.
- Koppisetty, B. R. B., Yejella, R. P., Pawar, A. K. M., Yarraguntla, S. R., Kollabathula, V. R., Dadi, V., & Naidu, C. G. (2023). Development of a validated RP-HPLC assay method for quantitative separation of Teriflunomide and its process-related impurities in bulk drugs. Journal of Applied Pharmaceutical Science, 13(1), 028-033.
- 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 chemistry, 18(1), 93.
- Dadi, V., Medapati, S., Baratam, J. K., Tatapudi, H. K., Challa, G. N., Yarraguntla, S. R., & Koppisetty, B. R. B. (2024). Quality by design assisted rp-hplc method for estimation of teriflunomide and its process impurities in drug substance. Journal of Faculty of Pharmacy of Ankara University, 48(3), 962-974.
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.