Development and validation of a stability indicating UPLC method for determination of darolutamide in its tablet formulation

Darolutamide is an orally active, second generation non-steroidal anti-androgen. The objective of this study was to develop a simple and fast stability indicating method for the determination of Darolutamide in bulk and tablets. Darolutamide was eluted on a Zorbax SB-Cis column (100X2.1mmX1.8µ) with a mobile phase of 8mM ammonium acetate, pH: 5.4: acetonitrile (66:34 v/v) in isocratic mode at a flow rate of 0.4 ml/min. The analyte was quantified using a 272 nm PDA detector. The chromatograms of darolutamide obtained with this method showed a well resolved retention time at 0.83 min of its excipients and degradation products. The area of the peak with respect to the concentration calibration curves, which were linear from 70 to 210 µg/ml, had a regression coefficient (r2) greater than 0.999. The detection limit (LOD) and the limit of quantification (LOQ) were found at 1.80 and 6.01 µg/mL respectively. Accuracy and precision have been determined and perfectly matched to the ICH standards. The study showed that the proposed UPLC method was simple, fast, robust and reproducible, which can be used for the evaluation of the purity and stability of the drug without interference from excipients or decomposition products of active pharmaceutical ingredients.