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Forced Degradation Studies of Amlodipine Besylate and Characterization of Its Major Degradation Products by LC-MS/MS

Divya Saxena1, Shailesh Damale2, Amit Joshi2, and Ajit Datar1
1. Guru Nanak Institute of Research and Development, Guru Nanak Khalsa College, Opp. Don Bosco School, Nathalal Parekh Marg, Matunga - east, Mumbai - 400 019, Maharashtra, India
2. Shimadzu Analytical India Pvt. Ltd.,Rushabh Chambers,Makwana Road, Marol, Andheri east, Mumbai -400059, Maharashtra, India
Abstract—The proposed study describes an isocratic reversed phase HPLC method for investigation of degradation products of Amlodipine Besylate API under different stress conditions (acid hydrolysis, base hydrolysis, oxidation and thermal degradation). Separation of Amlodipine and its degradation products was achieved on a phenomenex C18 column. Amlodipine was found to degrade the most under base hydrolysis (about 99%) followed by acid hydrolysis (about 87%) then in oxidation (about 12%) and negligible in thermal degradation (about 0.2%). Structures of the degradation products were studied using a Triple Quadrapole Mass Spectrometer. A separate gradient LC-MS method was developed for this purpose. Analysis was done using Shim-pack XR ODS column. Depending on the degradation type, possible chemical reactions were predicted and supported by fragmentation data obtained from LC-MS. One major degradation product from each of the stress conditions was isolated using preparative LC technique. These degradation products were obtained in solid form using Rotavap and lyophilizer and were then analyzed by NMR and IR spectroscopy to confirm their structural details. 

Index Terms—amlodipine besylate, forced degradation studies, degradation products, LC, LC-MS

Cite: Divya Saxena, Shailesh Damale, Amit Joshi, and Ajit Datar, "Forced Degradation Studies of Amlodipine Besylate and Characterization of Its Major Degradation Products by LC-MS/MS," International Journal of Life Sciences Biotechnology and Pharma Research, Vol. 3, No. 3, pp. 196-207, July 2014.
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