Identification and characterization of stress degradation products of dronedarone hydrochloride employing LC-UV/PDA, LC-MS/TOF and MSn studies
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- 作者：Renu Chadhaa ; renukchadha@rediffmail.com" class="auth_mail" title="E-mail the corresponding author ; Alka Balia ; Gulshan Bansalb
- 关键词：Dronedarone ; Stress degradation ; Chromatographic ; LC&ndash ; MS ; Stability indicating ; Validation
- 刊名：Journal of Pharmaceutical and Biomedical Analysis
- 出版年：2016
- 出版时间：25 January 2016
- 年：2016
- 卷：118
- 期：Complete
- 页码：139-148
- 全文大小：2028 K
文摘
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Stress degradation studies were carried out on dronedarone HCl.
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Maximum degradation was under alkaline hydrolytic and photolytic conditions.
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Six degradation products were characterized through MSn and LC–MS studies.
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MSn studies were used to establish the fragmentation pattern of the drug.
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Degradation pathway was postulated for the drug.