Development and validation of a stability indicating HPLC method for the quantification of impurities in Erlotinib hydrochloride dosage forms

Abstract

This work is aimed to develop a stability indicating high performance liquid chromatographic method for the analysis of Erlotinib HCl related compounds in pharmaceutical dosage forms. Separation was achieved on waters X- terra RP18 (150x4.6mm, 3.5µm) column using a gradient method. Here in this work mobile phase A is 0.01 M NaH2PO4 buffer (pH 4.5) and mobile phase B contains a mixture of 0.01 Na H2PO4, (pH 4.5) buffer and methanol in the ratio  20:80  (%V/V), respectively. The flow rate is 1.0 mL/min and the detection wavelength is monitored at 245 nm. The method was validated for specificity, limit of quantification, limit of detection, linearity, accuracy, method precision, intermediate precision, robustness and stability. Retention times of Erlotinib, impurity A and impurity B are 17.137, 6.650 and 10.346 minutes respectively. Linearity was observed over the concentration ranges of LOQ level to 1.5µg/mL of each impurity with correlation coefficient of 0.999. The RSD values of recoveries of impurities were found as less than 10%. The drug was subjected to stress condition of hydrolysis, oxidation, photolysis and thermal degradation. Extensive degradation was found in acid medium and alkaline medium. Minimum degradation was found in thermal and oxidative conditions while there was no degradation found in photolytic condition.