Development and validation of Anastrozole In RP- HPLC

Abstract

A  brand-new RP-HPLC technique that is easy to use, quick, accurate, precise, and repeatable for estimating anastrozozole in bulk and in commercial formulations. Anastrozole was successfully separated using an isocratic method of separation on a Develosil ODS HG-5 RP C18, 5μm, 15cmx4.6mm i.d. column. Methanol: Phosphate buffer (0.02M, pH-3.6) was used in a 45:55% v/v ratio at a flow rate of 1.0 mL/min, and the detection was done at 255 nm. The method's linearity, sensitivity, accuracy, precision, specificity, and robustness were all verified in accordance with ICH recommendations. For anastrozozole, the response was shown to be linear within the 12-28 mcg/mL medication concentration range. Anastrozole's correlation coefficient was discovered to be 0.9995. Anastrozole's LOD and LOQ were determined to be 5.004μg/mL and 15.164μg/mL, respectively. The fact that the suggested procedure produced a fair percentage recovery for anastrozozole suggests that it is quite accurate. The method's specificity demonstrates a strong connection between the sample solution's and the standard solution's retention periods. As a result, the suggested approach precisely ascertains the analyte in the sample without the excipients from pharmaceutical dosage forms interfering.