Abstract

A novel reversed-phase high performance liquid chromatographic (HPLC) technique for the determination of Erlotinib and its Pharmaceutical Dosage form has been optimized and validated as per ICH Guidelines. Erlotinib was separated on a Symmetry ODS (C18) RP Column, 250 mm x 4.6 mm, 5µm with a composition of Phosphate Buffer and Methanol in the ratio of 46:54%v/v (pH-3.2) adjusted by addition of 0.1% orthophosphoric acid solution) as mobile phase at a flow rate of 1.0 mL min-1. The effluent was monitored by UV detection at 206 nm. Calibration plots were linear in the range of 60 to 140 μg mL-1 and the LOD and LOQ were 0.08 and 0.24 μg mL-1, respectively. The whole technique is developed and validated as per International Council for Harmonization (ICH) guidelines. The proposed method is robust, sensitive, rapid and successful and helpful in the regions where regulatory agencies recommend HPLC analytical method.