Identification, synthesis and structural characterization of process related and degradation impurities of acrivastine and validation of HPLC method

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• 作者：Ajay Kumar^b ; Subba Rao Devineni^a ; Shailender Kumar Dubey^a ; Pradeep Kumar^b ; Vishal Srivastava^b ; Girish Ambulgekar^a ; Mohit Jain^b ; Dharmendra Kumar Gupta^a ; Gurmeet Singh^b ; Rajesh Kumar^b ; S.G. Hiriyanna^b ; Pramod Kumar^a ; ^{pramodkumar@microlabs.in}
• 关键词：Acrivastine ; Forced degradation ; Impurities ; Identification ; Characterization ; Method validation
• 刊名：Journal of Pharmaceutical and Biomedical Analysis
• 出版年：2017
• 出版时间：30 January 2017
• 年：2017
• 卷：133
• 期：Complete
• 页码：15-26
• 全文大小：1026 K
• 卷排序：133

文摘

First reported stability indicating method for the determination of related substances of acrivastine. Separation of geometrical isomer (Imp-III) in the same method. Identification, synthesis and characterization of new impurities by IR, NMR and LC/ESI–MSn. Forced degradation studies as per ICH guidelines. Method validation data shows that the method is highly sensitive, specific, selective, rugged and robust for the analysis.