Journal
Identification and Synthesis of Impurity for Amlodipine and Analytical Method Development
Received: January 2026 | Accepted: February 2026 | Published: March 2026
Abstract
Despite available data and research on impurities of Amlodipine there is a scope for further development of analytical method for identification of crucial impurities in the available samples. This paper undertakes the identification of crucial impurities Impurity G and impurity 6 in amlodipine as API using in silico method of ADMET prediction. The identified impurities were synthesized using simple, organic chemistry method and were characterized using IR, NMR and Mass spectroscopy. Subsequently a reverse phase HPLC based method was developed and validated for identification and quantification of these impurities.
Authors
Sandhya Mishra, Anita Ayre, Mushtaque. A. S. Shaikh
Keywords :
Amlodipine; Impurity G; Impurity 6; ADMET Prediction; RP-HPLC.
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