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).