Abstract

A REVIEW ON SPECTROPHOTOMETRIC ESTIMATION OF CINACALCET HYDROCHLORIDE AND DESIGN EXPERT SUPPORTED QBD APPROACH FOR CHROMATOGRAPHIC METHOD DEVELOPMENT AND VALIDATION OF CINACALCET HYDROCHLORIDE IN ITS BULK AND TABLET DOSAGE FORM

Pathan Vasim*, Dhananjay Landge, Jaydip Pawar and Priyanka Manmode

Abstract

Cinacalcet is used alone or with other medications to treat secondary hyperparathyroidism (a condition in which the body produces too much parathyroid hormone [a natural substance needed to control the amount of calcium in the blood] which can cause serious problems with the bones, heart, blood vessels, and lungs) in patients with chronic kidney disease (a condition in which the kidneys stop working slowly and gradually) who are being treated with dialysis. This research work aimed to develop and validate spectrophotometric and chromatographic methods for the estimation of Cinacalcet hydrochloride (CCH) in bulk and tablet dosage form. Two UVspectrophotometric methods, zero-order derivative and area under the curve (AUC) method, were developed and validated using 0.1 N methanolic HCl as solvent and detection at 282 nm and 277-287 nm, respectively. Both methods showed good accuracy, precision, reproducibility, robustness, and economy, with % RSD within 2. The HPTLC method was developed using the Quality by Design (QBD) approach and the mobile phase consisted of Toluene: Ethyl acetate: Methanol (8:1.2:0.8 v/v/v) with detection at 281 nm. The methods were found to be accurate, precise, reproducible, robust, and economical. Solubility analysis and melting point analysis were also performed to identify CCH. The precision and accuracy of the methods were determined by intraday and inter-day precision and standard addition method, respectively. The method was validated according to ICH Q2 (R1) guidelines. The study also included solubility and melting point analysis, as well as precision and accuracy determination by the standard addition method. The proposed methods can be successfully applied for the determination of CCH in its bulk and tablet dosage form.

Keywords: Cinacalcet hydrochloride, UV-Vis spectroscopy, HPTLC, Quality by design, Design of experiments.