Validated Rp-Hplc Method Development And Validation For The Estimation Of Anti-Neoplastic Agent Anastrozole In Pure Form And Marketed Pharmaceutical Tablet Dosage Form
Keywords:Anastrozole, RP-HPLC, Accuracy, Precision, Robustness, ICH Guidelines.
A new, simple, rapid, precise, accurate, and reproducible RP-HPLC method for estimation of Anastrozole in bulk form and marketed formulation. Separation of Anastrozole was successfully achieved on a Develosil ODS HG-5 RP C18, 5µm, 15cmx4.6mm i.d. column in an isocratic mode of separation utilizing Methanol: Phosphate buffer (0.02M, pH-3.6) in the ratio of 45:55% 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 Anastrozole. The correlation coefficient was found to be 0.9995 for Anastrozole. The LOD and LOQ for Anastrozole were found to be 5.004µg/mL and 15.164µg/mL respectively. The proposed method was found to be a good percentage recovery for Anastrozole, which indicates that the proposed method is highly accurate. The specificity of the method shows good correlation between retention times of the 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.