Research Article | Volume: 7, Issue: 10, October, 2017

Synthesis and establishment of Amlodipine impurity G reference standard

Ly Dieu Ha Trang Thi Diem Nguyen Tri Minh Le   

Open Access   

Published:  Oct 30, 2017

DOI: 10.7324/JAPS.2017.71015
Abstract

Dimethyl-4-(2-chlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate which is impurity of amlodipine besilate was synthesized. Hantzsch condensation of methyl acetoacetate with 2-chlorobenzadehyde in 2-propanol at heated under reflux temperature at 85 oC for about 10 hours yielded the yellow powder. This product was purified by column chromatography and the structure was identified by spectroscopic methods (IR, MS, NMR), that was characterized amlodipine impurity G (dimethyl -4-(2-chlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate). The quality of the impurity was determined by high performance liquid chromatography HPLC method and validated by guideline of The International Conference on Harmonization 2003 Then this impurity was determined homogeneity and assigned value to establish reference standard as Appendix 3 of World Health Organization (WHO technical series 943, 2006) and Statistical methods for use in proficiency testing by inter-laboratory comparison, International Organization for Standardization (ISO 13528), 2005.


Keyword:     Hantzsch condensation amlodipine impurity G WHO ISO 13528.


Citation:

Ha LD, Nguyen LTD, Le TM. Synthesis and establishment of Amlodipine impurity G reference standard. J App Pharm Sci, 2017; 7 (10): 105-110.

Copyright: © The Author(s). This is an open-access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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