Separation, Identification and Structural Elucidation of a New Impurity in the Drug Substance of Amlodipine Maleate Using LC-MS/MS, NMR and IR

Title
Separation, Identification and Structural Elucidation of a New Impurity in the Drug Substance of Amlodipine Maleate Using LC-MS/MS, NMR and IR
Author(s)
박정학G.V.Ram Reddy[G.V.Ram Reddy]프라빈쿠마르B. V. Reddy[B. V. Reddy]Jadi Sreeramulu[Jadi Sreeramulu]
Keywords
TANDEM MASS-SPECTROMETRY; LIQUID-CHROMATOGRAPHY; QUANTIFICATION; BESYLATE; SERUM; ACID
Issue Date
201012
Publisher
CROATIAN CHEMICAL SOC
Citation
CROATICA CHEMICA ACTA, v.83, no.4, pp.443 - 449
Abstract
Amlodipine maleate is a maleate salt of 3-ethyl 5-methyl 2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate. An unknown impurity at m/z 392.2 for [M+H](+) ion has been detected during the accelerated stability analysis (40 degrees C/75 % RH) of amlodipine maleate drug substance by reverse-phase high performance liquid chromatography mass spectrometry (RP-HPLC-MS). MS and MS/MS spectra of amlodipine maleate and unknown impurity are obtained using HPLC-MS/MS equipped with positive electrospray ionization (ESI). The nuclear magnetic resonance (NMR) and infrared (IR) spectra of the unknown impurity are recorded after isolation of the impurity by preparative HPLC. Based on MS, NMR and IR spectral data, the structure of the unknown impurity was proposed as 5-ethyl-7-methyl-6-(2-chlorophenyl)-8-methyl-3,4,6,7-tetrahydro-2H-1,4-benzoxazine-5,7-dicarboxylate.
URI
http://hdl.handle.net/YU.REPOSITORY/23250
ISSN
0011-1643
Appears in Collections:
이과대학 > 화학생화학부 > Articles
문과대학 > 중국언어문화학과 > Articles
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