Development and Validation RP-HPLC Method for Estimation of Cinacalcet in Bulk and Tablet Dosage Form

The objective of the method was to develop a simple, rapid, efficient, cost effective and reproducible, stability indicating reverse phase high performance liquid chromatography method (RP-HPLC) for the quantification of cinacalcet in bulk and pharmaceutical dosage form. As very few analytical methods have been reported for the analysis of cinacalcet by chromatography, we aimed to develop a method which would be simple with optimum retention time by the use of simple mobile phase, which results in the economic method that can be used for routine analysis of the drug. The RP-HPLC analysis was carried out on Inertsil ODS C18 with a mobile phase of methanol, acetonitrile and water in the ratio of 70:15:15 v/v/v. Detection was carried out at 280 nm using a PDA detector. The method was validated for linearity, accuracy, precision, LOD, LOQ and robustness as per ICH guidelines. The method was found to be linear in the range of 10-50 µg/ml. Limit of detection and limit of quantitation was found to be 0.22 and 0.74 µg/ml respectively. Recovery was found to be in the range 99.7-100.02% and precision less than 1%. The developed method was successfully applied for the estimation of cinacalcet in marketed tablet formulation (PTH 30) and percentage assay was found to be 100.8 %. The developed RP-HPLC method was simple, rapid, accurate, precise and stability indicating for the quantification of cinacalcet in bulk and tablet dosage form.