A NEW ANALYTICAL RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE QUANTITATIVE ESTIMATION OF DACOMITINIB IN API FORM AND MARKETED PHARMACEUTICAL DOSAGE FORM

Rayagonda Rama Devi*, G. Kalyani, Vijaya Kuchana and Pasupuleti Sunitha

ABSTRACT

A new, simple, rapid, precise, accurate and reproducible RP-HPLC method for estimation of Dacomitinib in bulk form and marketed formulation. Separation of Dacomitinib was successfully achieved on a Symmetry ODS C18 (4.6 x 250mm, 5m) 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 Dacomitinib. The correlation coefficient was found to be 0.999 for Dacomitinib. The LOD and LOQ for Dacomitinib were found to be 1.1μg/mL and 3.2μg/mL respectively. The proposed method was found to be good percentage recovery for Dacomitinib, 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.

Keywords: Dacomitinib, RP-HPLC, Accuracy, Robustness, Method, Validation, ICH Guidelines.