Analytical Method Development and Validation of a Stability-Indicating RP-HPLC Method for the Analysis of Danazol in Pharmaceutical Dosage Form

Danazol is an endocrine metabolic agent or anti gonadotropin drug. The aim of this study was to develop a accurate, specific, linear, simple, rapid, precise, reliable and stability indicating RP-HPLC analytical method for the determination of Danazol in pharmaceutical dosage form. The chromatographic separation was performed using phenomenex C₁₈ column (150X4.6mm, 5μm) in RP-HPLC with mobile phase consisting of acetonitrile:potassium dihydrogen orthophosphate (70:30, v/v) with flow rate of 1ml/min and detection wave length at 285nm was optimized and fixed. The Danazol was properly resolved with a run time of 4.9 min. Linearity was performed for Danazol in the range of 10-120μg /ml (R²=0.9986). The percentage recovery for Danazol was found to be 98.87%-100.69%. The developed analytical method has been validated in terms of accuracy precision, specificity, linearity, and robustness which were within the acceptance limit according to ICH Q2 (R1) guidelines. Danazol was subjected to stress conditions including acidic, alkaline, oxidation, and thermal degradation and drug found to be more sensitive towards alkaline hydrolysis and all the degradation products were found to be well separated from the principal peak, which means that the Danazol peaks were highly pure in all chromatograms obtained. The results represents that the developed method was successfully employed for the routine quality control and stability analysis of Danazol in pharmaceutical dosage forms.