Development and Validation of a RP-HPLC Method for the Analysis of Darolutamide in Bulk and Pharmaceutical Dosage form
Abstract
A new, simple, rapid, precise, accurate and reproducible RP-HPLC method for estimation of Darolutamide in bulk form and marketed pharmaceutical dosage forms. Separation of Darolutamide was successfully achieved on a Symmetry ODS C18 (4.6 x 250mm, 5m) column in an isocratic mode of separation utilizing Acetonitrile: Methanol in the ratio of 80: 20% v/v at a flow rate of 1.0 mL/min and the detection was carried out at 272nm. The method was validated according to ICH guidelines for linearity, sensitivity, accuracy, precision, specificity and robustness. The response was found to be linear in the drug concentration range of 10-50mcg/mL for Darolutamide. The correlation coefficient was found to be 0.999 for Darolutamide. The LOD and LOQ for Darolutamide were found to be 1.1µg/mL and 3.2µg/mL respectively. The proposed method was found to be good percentage recovery for Darolutamide, which indicates that the proposed method is highly accurate. The specificity of the method shows good correlation between retention times of standard solution with the sample solution. Therefore, the proposed method specifically determines the analyte in the sample without interference from excipients of pharmaceutical dosage forms.
How to Cite This Article
CH Kantlam, Kalpana, V Prashantu, Abdul Asad Khan, B Vamshi Krishna, B Kalyani, D Niriksha (2025). Development and Validation of a RP-HPLC Method for the Analysis of Darolutamide in Bulk and Pharmaceutical Dosage form . International Journal of Pharma Growth Research Review (IJPGARR), 2(4), 09-15.