Abstract
AbstractThis study intends to develop an essential simultaneous analysis method for the stability study of the combination drugs hydrochlorothiazide, (S)‐amlodipine besylate, and olmesartan medoxomil and identify degradation products. A stress test of the combination drug was performed under thermal/humidity conditions to identify decomposition products expected to be generated under long‐term storage conditions. Six unidentified degradation products were generated from (S)‐amlodipine besylate and olmesartan medoxomil, except for those identified. Unspecified degradation products were identified by degradation prediction software with LC–MS/MS, and genotoxicity was predicted by toxicity prediction software. In silico toxicity, six degradation products were expected to be nonmutagenic. This study describes the development of an analytical method to predict degradation products and determine whether the degradation products are genotoxic. This process will be helpful in further forced degradation studies to predict the toxicity of potential impurities.
Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: 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.
