A Reverse phase HPLC method Development and Validation of 2,4,6 Trifluro Benzoic acid and its impurities: A Key Raw Material Used In Preparation of Anti Migraine Drug Lasmiditan Hemisuccinate

Document Type : Original Article


R&D Center (API), Uquifa India Private Limited, CSIR-IICT, D-112, Discovery Building, Tarnaka, Hyderabad, Telangana, India -50007


A novel gradient reverse phase liquid chromatographic (RP-HPLC) method is developed and validated for the determination of purity of 2,4,6 Trifluro benzoic acid (TBA) in presence of its related impurities. TBA is very important key raw material used in the process development of Active Pharmaceutical Ingredient (API), Lasmiditan Hemisuccinate. The impurities formed during the synthesis of TBA will diminishes the pharmacological quality of the Lasmiditan Hemisuccinate. Hence, the stringent control of TBA and its related impurities were significantly important to achieve the niche quality of Lasmiditan Hemisuccinate. This HPLC method developed by using Zorbax SB-Aq, 5 µm, 4.6 x 250 mm column with mobile phase containing a gradient mixture of solvent A and B. The buffer is 0.1% triethyl amine solution is solvent A and acetonitrile, methanol, water in the ratio of 700:200:100 v/v/v solvent mixture is solvent B. The eluted compounds monitored at 205 nm. This method validated as per International Conference on Harmonization (ICH) guidelines with respect to specificity, limit of detection, limit of quantitation, precision, linearity, accuracy and system suitability