Development and validation of stability indicating RP-HPLC method for estimation of teriflunomide in active pharmaceutical ingredient
Bhavya Mehta, Pravin Prajapat and Yatin Gohil
Developed method is a rapid, simple and Reverse Phase-High Performance Liquid Chromatography (RP-HPLC) method for determination of teriflunomide. The HPLC separation was achieved on Agilent-1260 Infinity series instrument with Eclipse XBD C18 (Agilent) column (150X4.6 mm, 5µm) using a mobile phase of acetonitrile and di-potassium hydrogen anhydrous (K2HPO4) solution (40:60; v/v) containing TEA (pH 7) at a flow rate of 1.0 ml/min. The method was validated for specificity, linearity, precision, accuracy, robustness and ruggedness. The elution of peak was rapid which s takes about 3.5 minutes. The method was found to be simple, specific, precise, accurate, linear and reproducible. The method can be applied for the quality control of commercial teriflunomide API (active pharmaceutical ingredient) to quantify the drug and to check the formulation content uniformity and purity of drug.
How to cite this article:
Bhavya Mehta, Pravin Prajapat, Yatin Gohil. Development and validation of stability indicating RP-HPLC method for estimation of teriflunomide in active pharmaceutical ingredient. Pharma Innovation 2017;6(9):440-449.