PMID- 27793392
OWN - NLM
STAT- MEDLINE
DCOM- 20170306
LR  - 20181202
IS  - 1873-3778 (Electronic)
IS  - 0021-9673 (Linking)
VI  - 1472
DP  - 2016 Nov 11
TI  - Comparison of ultra-high performance methods in liquid and supercritical fluid 
      chromatography coupled to electrospray ionization - mass spectrometry for 
      impurity profiling of drug candidates.
PG  - 117-128
LID - S0021-9673(16)31395-4 [pii]
LID - 10.1016/j.chroma.2016.10.045 [doi]
AB  - Impurity profiling of organic products synthesized as possible drug candidates 
      represents a major analytical challenge. Complementary analytical methods are 
      required to ensure that all impurities are detected. Both high-performance liquid 
      chromatography (HPLC) and supercritical fluid chromatography (SFC) can be used 
      for this purpose. In this study, we compared ultra-high performance HPLC (UHPLC) 
      and ultra-high performance SFC (UHPSFC) using a large dataset of 140 
      pharmaceutical compounds. Four previously optimized methods (two on each 
      technique) were selected to ensure fast high-resolution separations. The four 
      methods were evaluated based on response rate, peak capacity, peak shape and 
      capability to detect impurities (UV). The orthogonality between all methods was 
      also assessed. The best UHPLC method and UHPSFC methods provided comparable 
      quality for the 140 compounds included in this study. Moreover, they were found 
      to be highly orthogonal. At last, the potential of the combined use of UHPLC and 
      UHPSFC for impurity profiling is illustrated with practical examples.
CI  - Copyright (c) 2016 Elsevier B.V. All rights reserved.
FAU - Lemasson, Elise
AU  - Lemasson E
AD  - Univ Orleans, Institut de Chimie Organique et Analytique (ICOA), CNRS UMR 7311, 
      Pole de Chimie, rue de Chartres, B.P. 6759, 45067 Orleans, Cedex 2, France.
FAU - Bertin, Sophie
AU  - Bertin S
AD  - Institut de Recherches Servier, 11 rue des Moulineaux, 92150 Suresnes, France.
FAU - Hennig, Philippe
AU  - Hennig P
AD  - Institut de Recherches Servier, 11 rue des Moulineaux, 92150 Suresnes, France.
FAU - Lesellier, Eric
AU  - Lesellier E
AD  - Univ Orleans, Institut de Chimie Organique et Analytique (ICOA), CNRS UMR 7311, 
      Pole de Chimie, rue de Chartres, B.P. 6759, 45067 Orleans, Cedex 2, France.
FAU - West, Caroline
AU  - West C
AD  - Univ Orleans, Institut de Chimie Organique et Analytique (ICOA), CNRS UMR 7311, 
      Pole de Chimie, rue de Chartres, B.P. 6759, 45067 Orleans, Cedex 2, France. 
      Electronic address: caroline.west@univ-orleans.fr.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
DEP - 20161018
PL  - Netherlands
TA  - J Chromatogr A
JT  - Journal of chromatography. A
JID - 9318488
RN  - 0 (Pharmaceutical Preparations)
SB  - IM
MH  - Chromatography, High Pressure Liquid/*methods
MH  - Chromatography, Supercritical Fluid/*methods
MH  - Datasets as Topic
MH  - *Drug Contamination
MH  - Pharmaceutical Preparations/*analysis
MH  - *Spectrometry, Mass, Electrospray Ionization
OTO - NOTNLM
OT  - High-resolution separations
OT  - Impurity profiling
OT  - Orthogonal methods
OT  - Performance comparison
OT  - Pharmaceutical ingredients
EDAT- 2016/10/30 06:00
MHDA- 2017/03/07 06:00
CRDT- 2016/11/07 06:00
PHST- 2016/05/03 00:00 [received]
PHST- 2016/09/17 00:00 [revised]
PHST- 2016/10/18 00:00 [accepted]
PHST- 2016/11/07 06:00 [entrez]
PHST- 2016/10/30 06:00 [pubmed]
PHST- 2017/03/07 06:00 [medline]
AID - S0021-9673(16)31395-4 [pii]
AID - 10.1016/j.chroma.2016.10.045 [doi]
PST - ppublish
SO  - J Chromatogr A. 2016 Nov 11;1472:117-128. doi: 10.1016/j.chroma.2016.10.045. Epub 
      2016 Oct 18.