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Development and Validation of Stability Indicative Analysis for Cinacalcet Hydrochloride and Stress Study

: 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.