Abstract

DEVELOPMENT AND VALIDATION OF A RP-HPLC METHOD FOR QUANTITATIVE ESTIMATION OF CINACALCET IN TABLET DOSAGE FORM

Debadash Panigrahi*, Amiyakanta Mishra and Sushant Kumar Sahu

Abstract

In the present work a simple, selective, accurate, precise and rapid RPHPLC method was developed for quantitative estimation of cinacalcet in tablet dosage form. This method was developed by using a C18 column with mobile phase a mixture of methanol and phosphate buffer (pH 6.8) in the ratio 60: 40 v/v at a flow rate 1.0 ml min-1. Detection of the drug was performed at 232nm using PDA detector. The developed method was validated as per ICH guideline for linearity, accuracy, precision, specificity, robustness and selectivity. The developed method was successfully applied for quantitative estimation of cinacalcet in its tablet dosage form (Ceracal) having retention time is 2.82 minute and percentage of drug content was found to be 100.45%. Validation study result revealed that the method is specific, accurate, precise, reliable and reproducible for estimation of cinacalcet in it’s dosage form. Concentration with in the range of 5-50 μg/ml was found to be linear. Limit of detection and limit of quantitation was found to be 0.32 and 0.91μg/ml respectively. Recovery concentration was found to be in the range 99.85-100.14%, with coefficient of variance (COV) < 2.0. High percentage of recovery and acceptance limit of statistical data for validation study assure that the developed method was suitable for estimation of cinacalcet in it’s bulk and dosage forms.

Keywords: Cinacalcet, RP-HPLC, Validation and Mobile Phase.