Development and validation of RP-HPLC method for the estimation of Erlotinib in pharmaceutical formulation

Abstract In this study, a simple, precise and accurate reverse phase high performance liquid chromatography was developed for the estimation of Erlotinib in bulk and pharmaceutical dosage forms. A reverse phase Merck C 18 column (250 cm × 4.6 mm × 5 μm) with mobile phase consisting of potassium dihydrogen orthophosphate and acetonitrile (70:30 V/V) having pH 5.0 was adjusted with orthophosphoric acid was used. The flow rate was 0.8 mL min −1 and the effluents were monitored at 246 nm. The retention time was found to be 4.54 min. The linearity of the drug was obtained in the range of 10–60 μg mL −1 . The results of analysis have been validated according to ICH guideline requirements for registration of human use.