Abstract:

A new, simple, rapid, precise, accurate and reproducible RP-HPLC method for estimation of Ziftomenib in bulk form and marketed pharmaceutical dosage forms. Separation of Ziftomenib was successfully achieved on a Symmetry ODS RP C18, 5µm, 15cmx4.6mm i.d. column in an isocratic mode of separation utilizing Methanol : Phosphate buffer (0.01M, pH-3.4) in the ratio of 30:70% v/v at a flow rate of 1.0 mL/min and the detection was carried out at 255nm. 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 12-28mcg/mL for Ziftomenib. The correlation coefficient was found to be 0.9995 for Ziftomenib. The LOD and LOQ for Ziftomenib were found to be 1.165µg/mL and 3.53µg/mL respectively. The proposed method was found to be good percentage recovery for Ziftomenib, 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.