ABSTRACT:
An accurate, precise and simple rapid reversed-phase high-performance liquid chromatographic method has been developed and validated for estimation of erlotinib a tablet dosage form. 250x4.6mm, 5µ particle, Inertsil ODS-3V C18 column was used with 0.03 M Potsssium dihydrogen orthophosphate in water pH 3.2 with Orthophospharic acid: Acetonitrile (55:45), as mobile phase at a flow rate of 0.8 mL min-1. PDA detection was performed at 246.0 nm. Injection volume is 20 µl and temperature is ambient. HPLC grade water: Acetonitrile (50:50 V/V) was used as a diluents. The method was validated for accuracy, precision, linearity, specificity and sensitivity in accordance with International Conference on Harmonisation guidelines. The method was successfully used for quantitative analysis of Erlotinib tablets. Total run time was 20 min, erlotinib eluted with retention time of 4.75 min. Validation revealed that the method is specific, accurate, precise, reliable and reproducible. Calibration plots were linear over the concentration ranges 5–40 µg mL-1. Intra- and inter-day relative standard deviation for erlotinib was less than 3.3 and 4.1%, respectively. The accuracy was analyzed by adding a standard drug and good recovery values were obtained for all drug concentrations used. The HPLC method developed in this study showed specificity and selectivity with linearity in the working range and good precision and accuracy, making it very suitable for quantification of erlotinib in its pharmaceutical formulations. The analytical procedure is reliable and offers advantages in terms of speed and low cost of reagents.