The analysis of improved RP-HPLC method for the separation and quantification of Erlotinib and its impurities are described. Samples are analysed by means of reverse phase (RP-HPLC) using an Kromasil C18, 250 x 4.6 mm, 5µm and the mobile phase consists of two channels A and B. Channel-A: pH 2.80 phosphate buffer and Channel-B: Acetonitrile. The flow rate is 1.2 ml/min. The column temperature was maintained at 50°C and sample temperature was maintained at 5°C, injection volume 10µL and wavelength fixed at 248nm UV-detection. The developed LC method was validated with respect to specificity, precision, linearity, ruggedness and robustness. Validation study compared as per ICH guideline.

Key words: Erlotinib, estimation of related substances, liquid chromatography.