Development and validation of stability indicating HPLC methods for related substances and assay analyses of amoxicillin and potassium clavulanate mixtures
刊名:Journal of Pharmaceutical and Biomedical Analysis
出版年:2017
出版时间:20 March 2017
年:2017
卷:136
期:Complete
页码:1-9
全文大小:1495 K
卷排序:136
文摘
New stability-indicating HPLC methods were developed for amox-clav mixtures. 18 amox and 6 clav impurities were successfully separated by the developed method. Both assay and related substances methods were validated according to ICH. Process related amox imp. P was synthesized and characterized by NMR and LC/MS. Stress-testing and stability studies of amox-clav mixtures were carried out.