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STABILITY INDICATING HPLC METHOD FOR THE ESTIMATION OF CINACALCET HYDROCHLORIDE API

A stability-indicating liquid chromatography method has been developed and validated for the determination of Cinacalcet hydrochloride in a laboratory mixture as well as in a tablet formulation developed in-house. Efficient chromatographic separation was achieved on phenomenex C18 column (150 mm×4.6 mm, 5.0 μm) with mobile phase containing Methanol: Water (70:30v/v) pH adjusted to 3.6 with dilute Orthophosphoric acid at a flow rate of 1.3 mL/min and the eluent was monitored at 271 nm using Shimadzu LC-10AT-VP & LC-20 AD with Spinotech (Winchrome) software. Linearity range was found to be between 50-300μg/ml and the linear regression coefficient was not more than 0.999. The values of % RSD are less than 2% indicating accuracy and precision of the method. The percentage recovery varies from 97-103%w/w. LOD and LOQ were found to be within limit. The system suitability parameters like tailing factor, number of theoretical plates, Asymmetry were found to be within limit. Forced degradation studies were performed by using this method. There was a significant degradation in the presence of 0.1M HCl, 0.1M NaOH, 30%H2O2, heat and light. The proposed method is simple, accurate and rapid and hence can be employed for