Stability Indicative Assay Development and Validation of Cinacalcet HCl

Abstract

The current study presents development and successive validation of simple, rapid, stability indicative HPLC method for quantitative assay of Cinacalcet Hydrochloride. with known process impurities namely, ethnamine impurity, mesylate impurity, and dehydro impurity. The isocratic mixture of acetonitrile and phosphate buffer pH 3.0 (1:1 v/v) and the YMC pack C4 column was used for elution. Flow rate was set to 1ml/ min and detection was carried out at 215nm. The specificity of method was demonstrated in presence of process impurity viz Impurity A, Impurity B, Impurity Cas well as by carrying out forced degradation. The method linearity was established in range of 40 ppm to 150 ppm with regression coefficient > 0.999. The % accuracy was 99.2 to 100.1. All other validation parameters comply ICH requirement.