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

The present research deals with development and validation of simple, economical, for Cinacalcet Hydrochloride along with its process impurities. The mobile phase consists of phosphate buffer (pH 3.0) and Acetonitrile. The YMC pack butyl column was used for separation. The LOD value for Cinacalcet and known impurities were about 0.17 ppm and 0.20 ppm respectively, whereas LOQ values were about 0.50 and 0.60 ppm. The regression coefficient was more than 0.999. The % accuracy for each impurity was within the range of 90 to 110. The method is capable to quantify the degradant impurities generated during stress study, thus proving stability indicative nature of method.