Abstract
Gefitinib was subjected to stress degradation conditions of hydrolysis (neutral, acidic and alkaline), oxidation, photolysis and thermal stress, as per the ICH guideline Q1A(R2). A UPLC-UV/PDA based stability-indicating method was developed for the drug and validated as per ICH guidelines. The drug showed significant degradation under acidic/alkaline/neutral hydrolytic, acidic/alkaline/neutral photolytic, thermal and oxidative stress conditions. In total, seven degradation products (I-VII) were formed, which could be separated from the drug by UPLC on a Kinetex® C18 (100 mm × 4.6 mm; 2.6 μ) column using isocratic elution method. Detection wavelength was selected as 257 nm. The developed method was extended to UPLC-MS/TOF studies and accurate mass spectral data was used to identify and characterize the degradation products. Out of the seven degradation products, five products (I-II; V-VII) could be characterized through their MS/TOF spectral data. The degradation pathway of the drug leading to generation of various products was postulated and this has not been reported so far.
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Disclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.