Determination of five potential genotoxic impurities in dalfampridine using liquid chromatography

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• 作者：Mohit Jain^a ; Vishal Srivastava^a ; Rajesh Kumar^a ; Vishal Dangi^a ; S.G. Hiriyanna^a ; Ajay Kumar^a ; ^{ajaykumar@microlabs.in} (Assistant General Manager) ; Pramod Kumar^b ; ^{pramodkumar@microlabs.in} (Sr. Vice-President)
• 关键词：Dalfampridine ; Genotoxic impurity ; RP-HPLC ; HILIC mode ; UV detector ; 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：27-31
• 全文大小：1023 K
• 卷排序：133

文摘

Novel method for simultaneous determination of five PGI’s in dalfampridine. The developed method is simple, highly sensitive and fully validated. The detection levels of all PGI’s are found to be low up to 7.25 ppm with respect to sample concentration.