Abstract
A NOVEL VALIDATED RP-HPLC METHOD FOR THE DETERMINATION OF RELATED SUBSTANCES OF CINACALCET HYDROCHLORIDE API

*Gaurav, Rashmi Mallya and Dr. Ravi Yadav

ABSTRACT

This article reports validated stability-indicating RP-HPLC method for the related substance of cinacalcet hydrochloride developed by separating its related substances and degradants on an Ascentis Express ES-CN (150mm × 4.6mm × 2.7μm) column using 10 mM aqueous solution of sodium perchlorate (pH 2.5 with perchloric acid) - acetonitrile as the mobile phase in a gradient mode of elution at a flow rate of 0.8 mL/min at 50°C. The column eluents were monitored by a photodiode array detector set at 215 nm with an autosampler temperature of 5˚C. The developed method was validated for system suitability, solution stability, specificity, linearity, range, accuracy, precision (repeatability), limit of detection, limit of quantitation and robustness according to ICH guidelines Q2 (R1). The forced degradation study of cinacalcet hydrochloride was carried out under acidic condition, basic condition, neutral condition, thermal condition, photodegradation, and oxidation conditions and the degradation products were separated. The linear range of the method was 0.4-1.5 μg/ml and limit of quantification of the Impurity-1, Impurity-2, Impurity-3, Impurity-4, Impurity-5, Impurity-6, Impurity-7 and Impurity-8 were found to be 0.07, 0.15, 0.04, 0.18, 0.17, 0.13, 0.14 and 0.07 μg/ml respectively. The method was successfully applied to separate the degradation products and related substances of cinacalcet hydrochloride.

Keywords: Cinacalcet Hydrochloride; Impurities; RP-HPLC; ICH guidelines; Stability Indicating; Method Development and Validation.


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