Validation of HPLC Method for Quantitative Determination of Gefitinib in Polymeric Nanoformulation

Abstract

Gefitinib was determined quantitatively in a nanoformulation using the proposed HPLC method. Effective elution was achieved by using a stationary phase of HyperClone (Phenomenex®) C₁₈ column (250 mm × 4.6 mm i.d., 5 μm, BDS 130 Å) and a mobile phase composed of acetonitrile and 40 mM ammonium formate buffer pH 2.5 (30 : 70, %v/v) at a flow rate of 1.0 mL/min. The samples were measured at 248 nm using UV detector. The column temperature was kept at 25°C; the run time was 7 min; the injection volume was 20 μL. Gefitinib was separated within 4.476 min. The correlation coefficient for the obtained calibration curve was found to be 0.998. The method was validated according to ICH Q2 (R1) guidelines for linearity, sensitivity, robustness, accuracy and precision. The LOD and LOQ were found to be 37.852 and 114.702 ng/mL, respectively.