Validated RP-HPLC method for Determination of Erlotinib HCl in Tablet Dosage forms and its Application to Stress Degradation Studies.

An accurate and precise stability-indicating RP-HPLC method has been developed and validated for the analysis of Erlotinib HCl in tablet dosage forms. The method was developed on a Qualisil Gold C18 (250×4.6mmi.d, 5μm particle size) analytical column using methanol: water in the ratio of 58:42(v/v) as the mobile phase. The instrumental settings were flow rate 1mL/min, column temperature 23oC and the detection wavelength of 246nm using a Photo Diode Array (PDA) detector. The method is linear over a range of 5-50μg/ml. The LOD and LOQ values were found to be 0.81μg/mL and 2.466μg/mL respectively. Erlotinib was exposed to acidic, alkaline, oxidative, photolytic, thermal stress conditions and these stressed samples were analyzed by the proposed method. The drug product was completely separated from the degradants which indicates that the method is specific. Key-words: ErlotinibHCl, RP-HPLC, Stress degradation studies.