Development and Validation of UV-VIS Spectrop...

Development and Validation of UV-VIS Spectrophotometric Method of Cinacalcet Hydrochloride by Using Forced Degradation Studies

Author Name : Mrs. Seema Gadge, Ms. Priyanka Varade, Ms. Rini Punathil

ABSTRACT

The aim of the present work is to develop and validate a simple, accurate and precise UV-VIS Spectrophotometric method for estimation of Cinacalcet hydrochloride in bulk and determination of percent degradation by using stress degradation conditions. Cinacalcet hydrochloride is an Oral Calcimimetic indicated for the treatment of secondary hyperparathyroidism (HPT) in patients on dialysis with end stage renal disease (ESRD), and in patients with parathyroid carcinoma to reduce hypercalcaemia. Cinacalcet hydrochloride is the first of a new class of drugs, the Calcimimetics, which act by increasing the sensitivity of calcium sensing receptors in the parathyroid gland. The solvent used was Methanol and an absorption maximum (λmax) of drug was found to be 281nm. The linear response was observed in the range of 5-15 μg/ml with regression coefficient 0.998. The method was validated for different parameters as per International Conference for Harmonization (ICH) guidelines. Cinacalcet hydrochloride was subjected to various stress degradation conditions recommended by ICH stress degradation studies were carried out to provide indications of stability indicating property of proposed method. The results indicated that Cinacalcet hydrochloride is stable under the experimental conditions. Hence, the proposed method wassuccessfully used for the routine analysis of Cinacalcet hydrochloride in quality control and clinical laboratories.

KeyWord: Cinacalcet HCL, Stress degradation studies, UV-VIS Spectrophotometry, Validation.