Stability Indicating Method Development, Validation and Forced Degradation Study for Vilazodone Hydrochloride API

The current study describes the short, stability indicative HPLC method development and successive validation of Assay Related Substances methods for Vilazodone Hydrochloride API. This also covers process impurities viz. Impurity A B. chromatographic conditions are similar except sample concentration. proposed utilizes C18 column (15 cm X 4.6 mm, 5 µ, make ZORBAX SB) mobile phase having Methanol 0.05 M KH2PO4 (55: 45 v/v). separation between all three analytes was achieved in less than five minutes. analytical these carried out successfully as per ICH other international guidelines. API subject to various stress like temperature, humidity, acidic basic hydrolysis, oxidative degradation. exposed samples analysed assay. mass balance each condition found more 98%.