DEVELOPMENT AND VALIDATION OF NOVEL STABILITY INDICATING UV SPECTROPHOTOMETRIC METHOD FOR THE ESTIMATION OF CINACALCET HYDROCHLORIDE IN BULK AND TABLET DOSAGE FORMS

摘要

A novel stability indicating UV spectrophotometric method for the quantitative determination of cinacalcet hydrochloride, a calcimimetic, in bulk and tablet dosage forms was developed in the present work. The parameters linearity, precision, accuracy, limit of detection and limit of quantitation were studied according to International Conference on Harmonization guidelines. UV spectroscopic determination was carried out at an absorption maximum of 281 nm using methanol as solvent. In the UV spectroscopic method, linearity over the concentration range of cinacalcet hydrochloride was found to be 15-35 ug/mL with a correlation coefficient of 0.9992. Results of the analysis were validated statistically and by recovery studies. Forced degradation studies were conducted under various conditions. The proposed method is simple, rapid, precise and accurate and can be used for the reliable quantitation of cinacalcet hydrochloride in commercial pharmaceutical dosage forms.