Abstract

STABILITY INDICATING ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF DAROLUTAMIDE IN PHARMACEUTICAL DOSAGE FORM

Nirav J. Harmani*, Ojas B. Patel, Neha S. Patel and Dr. Harsha U. Patel

ABSTRACT

A simple, rapid, economical, precise and accurate RP-HPLC method for Darolutamide in its Pharmaceutical Dosage Form has been developed. A reverse phase high performance liquid chromatographic method was developed for the Darolutamide in its Pharmaceutical Dosage Form. The separation was achieved by Hypersil BDS C18 (250 mm x 4..6 mm, 5μ) column and Acetonitrile: Phosphate Buffer, pH 3.0 (20:80) as mobile phase, at a flow rate of 1 mL/min. Detection was carried out at 242 nm. Retention time of Darolutamide was found to be 10.303 min. The method has been validated for linearity, accuracy and precision. Linearity observed for Darolutamide 25-75 μg/mL. Developed method was found to be accurate, precise and rapid for estimation of Darolutamide in its Dosage Form. The drug was subjected to stress condition of hydrolysis, oxidation, photolysis and Thermal degradation, Considerable Degradation was found in alkaline degradation. The proposed method was successfully applied for the estimation of Darolutamide in Pharmaceutical dosage form.

Keywords: Darolutamide, Stability Indicating RP-HPLC Method, Validation.