Forced Degradation Study Of Gefitinib

Abstract

HPTLC method was developed for the estimation of Gefitinib & the degradation products of gefitinib in various stress conditions. Samples were applied in form of band and the study was performed on the TLC aluminium plates (60-F254). Composition of mobile phase consist of MeOH: CHCl3 (7 : 3 v/v). Scanning of the TLC plates was done by TLC Scanner III. Wavelength was set at 332 nm and then it was used for the evaluation of plates in Absorbance mode. The mobile phase in chamber was allowed to be saturated for 20 min and development distance was kept at 80 mm. Degradation studies indicated that Gefitinib was susceptible in Acid Hydrolysis, Alkaline Hydrolysis and Oxidation. Gefitinib was not susceptible to Neutral degradation, Thermal degradation and Photodegradation. Degradation products of Gefitinib were separated from pure Gefitinib drug with different Rf values. In concentration range of 200 to 1200 ng per band, the calibration curve was determined with the linear regression analysis and the results obtained results revealed a strong linear relation with R2 = 0.9941. The method was validated as per ICH Guidelines Q2. Linearity, precision, accuracy, specificity, and robustness of the method was determined. The HPTLC approach can easily isolate a compound from its degradation product and can be used in a variety of applications.