Pedram Ebrahimnejad, Fatemeh Shahlaee and Kian Navaee
Pharmaceutical Sciences Research Center, Mazandaran University of Medical Sciences, Sari, Iran
A simple, selective, rapid, sensitive, precise and economical RP-HPLC method has been developed and validated for the determination of Cinacalcet in tablet dosage form. Efficient chromatographic separation was achieved on a ODS C18 column (250 mm x 4.6mm x 5 μm) using a mobile phase composition of acetonitrile and phosphate buffer in the ratio of 70:30 v/v, at a flow rate of 1.5 mL/min. Detection was carried out at 224 nm using a UV detector. Proposed method was validated for precision, accuracy, linearity and range, specificity and robustness according to ICH guidelines. The retention time of obtained chromatogram was 16.5 min.
Limit of detection and limit of quantitation was found to be 1.52 and 4.6 μg/ml respectively. The values of % RSD are less than 2% indicating accuracy and precision of the method. The developed method of assay was linear on calibration curve over the concentration range of 12-18 μg/ml for Cinacalcet.
All the validation parameters were within the acceptance range. The developed RP-HPLC method was simple, rapid, accurate, and precise and stability indicating for the quantification of cinacalcet in bulk and tablet dosage form and therefore suitable for the determination of cinacalcet for the quality control assay.