Identification, isolation and characterization of process related impurities in ezetimibe
Srikanth Guntupalli
1
,
Uttam Kumar Ray
2
,
N. Murali
2
,
P. C. Gupta
2
,
Vundavilli Jagadeesh Kumar
2
,
D Satheesh
2
,
Md. Aminul Islam
2
1
Institute of Science and Technology, Jawaharlal Nehru Technological University, Kukatpally, Hyderabad 500085, India
|
2
Chemical Research and Development, Aurobindo Pharma Limited, Indrakaran (V), Sangareddy (M), Medak District 502329, Andhra Pradesh, India
|
Publication type: Journal Article
Publication date: 2014-01-01
scimago Q2
wos Q2
SJR: 0.628
CiteScore: 6.4
Impact factor: 3.1
ISSN: 07317085, 1873264X
PubMed ID:
24176742
Drug Discovery
Spectroscopy
Pharmaceutical Science
Clinical Biochemistry
Analytical Chemistry
Abstract
During the synthesis of ezetimibe, two process related impurities were detected were HPLC analysis at levels ranging from 0.05 to 0.8%. These two impurities were isolated by column chromatography and co-injected with ezetimibe sample to confirm the retention times in HPLC. These two impurities were characterized as 2-(4-hydroxybenzyl)-N,5-bis(4-fluorophenyl) pentanamide (impurity-I) and 1-(4-fluorophenyl)-3(3-(4-fluorophenyl)propyl)-4-(4-hydroxyphenyl)azetidin-2-one (impurity-II). Isolation, structural elucidation of these impurities by spectral data ((1)H NMR, (13)C NMR, MS and IR) and probable mechanism of their formation have been discussed.
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GOST
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Guntupalli S. et al. Identification, isolation and characterization of process related impurities in ezetimibe // Journal of Pharmaceutical and Biomedical Analysis. 2014. Vol. 88. pp. 385-390.
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Guntupalli S., Ray U. K., Murali N., Gupta P. C., Kumar V. J., Satheesh D., Islam M. A. Identification, isolation and characterization of process related impurities in ezetimibe // Journal of Pharmaceutical and Biomedical Analysis. 2014. Vol. 88. pp. 385-390.
Cite this
RIS
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TY - JOUR
DO - 10.1016/j.jpba.2013.09.020
UR - https://doi.org/10.1016/j.jpba.2013.09.020
TI - Identification, isolation and characterization of process related impurities in ezetimibe
T2 - Journal of Pharmaceutical and Biomedical Analysis
AU - Guntupalli, Srikanth
AU - Ray, Uttam Kumar
AU - Murali, N.
AU - Gupta, P. C.
AU - Kumar, Vundavilli Jagadeesh
AU - Satheesh, D
AU - Islam, Md. Aminul
PY - 2014
DA - 2014/01/01
PB - Elsevier
SP - 385-390
VL - 88
PMID - 24176742
SN - 0731-7085
SN - 1873-264X
ER -
Cite this
BibTex (up to 50 authors)
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@article{2014_Guntupalli,
author = {Srikanth Guntupalli and Uttam Kumar Ray and N. Murali and P. C. Gupta and Vundavilli Jagadeesh Kumar and D Satheesh and Md. Aminul Islam},
title = {Identification, isolation and characterization of process related impurities in ezetimibe},
journal = {Journal of Pharmaceutical and Biomedical Analysis},
year = {2014},
volume = {88},
publisher = {Elsevier},
month = {jan},
url = {https://doi.org/10.1016/j.jpba.2013.09.020},
pages = {385--390},
doi = {10.1016/j.jpba.2013.09.020}
}