Development and validation of stability indicating HPLC methods for related substances and assay analyses of amoxicillin and potassium clavulanate mixtures

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• 作者：Esen Bellur Atici ; ^{ebellur@deva.com.tr} ; ^{esenbellur@yahoo.com} ; ^{esenbellur@yahoo.com} ; Yü ; cel Yazar ; Ç ; ağan Ağtaş ; Nurten Ridvanoğlu ; Bekir Karlığa
• 关键词：Amoxicillin ; Clavulanic acid ; Related substances ; Assay ; Validation ; Stress-testing
• 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.