PMID- 27261527
OWN - NLM
STAT- MEDLINE
DCOM- 20180327
LR  - 20191210
IS  - 1945-239X (Electronic)
IS  - 0021-9665 (Linking)
VI  - 54
IP  - 8
DP  - 2016 Sep
TI  - Simultaneous Determination of Genotoxic Impurities in Fudosteine Drugs by GC-MS.
PG  - 1277-81
LID - 10.1093/chromsci/bmw070 [doi]
AB  - A simple, sensitive and reliable gas chromatography mass spectrometry (GC-MS) 
      method has been developed, optimized and validated for the simultaneous 
      determination of 3-chloro-1-propanol (CHP), 1,3-dichloropropane (DCP), 
      3-chloropropylacetate (CPA) and chloropropyl hydroxypropyl ether (CHE) contents 
      in fudosteine, using chlorobenzene as internal standard. Efficient 
      chromatographic separations were achieved on an Agilent J&W DB-WAXetr, 30 m long 
      with 0.32 mm i.d., 1.0 microm particle diameter column that consists of bonded and 
      cross-linked polyethylene glycol as a stationary phase by passing helium as the 
      carrier gas. The analytes were extracted in dichloromethane and monitored by gas 
      chromatography electron ionization mass spectrometry (GC-EI-MS) with selective 
      ion monitoring (SIM) mode. The performance of the method was assessed by 
      evaluating specificity, precision (repeatability and reproducibility), 
      sensitivity, linearity and accuracy. The limit of detection and limit of 
      quantification established for CHP, DCP, CPA and CHE were in the range of 
      0.05-0.08 microg mL(-1) and 0.10-0.17 microg mL(-1), respectively. The recoveries for 
      CHP, DCP, CPA and CHE were in the range of 92.0-101.5%. The results proved that 
      the method is suitable for the simultaneous determination of contents of CHP, 
      DCP, CPA and CHE in fudosteine.
CI  - (c) The Author 2016. Published by Oxford University Press. All rights reserved. For 
      Permissions, please email: journals.permissions@oup.com.
FAU - Gooty, Amarnatha Reddy
AU  - Gooty AR
AD  - Aurobindo Pharma Limited Research Centre-II, Survey No. 71 & 72, Indrakaran 
      Village, Sangareddy Mandal, Medak 502 329, Andhra Pradesh, India 
      gooty_amar9@yahoo.com.
FAU - Katreddi, Hussain Reddy
AU  - Katreddi HR
AD  - Department of Chemistry, Sri Krishnadevaraya University, Anantapur 515 003, 
      India.
FAU - S, Raghavender Reddy
AU  - S RR
AD  - Aurobindo Pharma Limited Research Centre-II, Survey No. 71 & 72, Indrakaran 
      Village, Sangareddy Mandal, Medak 502 329, Andhra Pradesh, India.
FAU - Hunnur, Raveendra K
AU  - Hunnur RK
AD  - Aurobindo Pharma Limited Research Centre-II, Survey No. 71 & 72, Indrakaran 
      Village, Sangareddy Mandal, Medak 502 329, Andhra Pradesh, India.
FAU - Sharma, Hemant Kumar
AU  - Sharma HK
AD  - Aurobindo Pharma Limited Research Centre-II, Survey No. 71 & 72, Indrakaran 
      Village, Sangareddy Mandal, Medak 502 329, Andhra Pradesh, India.
FAU - Masani, Narendra Kumar
AU  - Masani NK
AD  - Aurobindo Pharma Limited Research Centre-II, Survey No. 71 & 72, Indrakaran 
      Village, Sangareddy Mandal, Medak 502 329, Andhra Pradesh, India.
LA  - eng
PT  - Journal Article
PT  - Validation Study
DEP - 20160603
PL  - United States
TA  - J Chromatogr Sci
JT  - Journal of chromatographic science
JID - 0173225
RN  - 0 (Mutagens)
RN  - 0 (Propanols)
RN  - 48TCX9A1VT (Cystine)
RN  - UR9VPI71PT (fudosteine)
SB  - IM
MH  - Chemistry Techniques, Analytical/*methods/standards
MH  - Cystine/*analogs & derivatives/chemistry
MH  - Drug Contamination
MH  - *Gas Chromatography-Mass Spectrometry
MH  - Limit of Detection
MH  - Mutagens/*analysis
MH  - Propanols/*analysis
MH  - Reproducibility of Results
EDAT- 2016/06/05 06:00
MHDA- 2018/03/28 06:00
CRDT- 2016/06/05 06:00
PHST- 2014/10/06 00:00 [received]
PHST- 2016/06/05 06:00 [entrez]
PHST- 2016/06/05 06:00 [pubmed]
PHST- 2018/03/28 06:00 [medline]
AID - bmw070 [pii]
AID - 10.1093/chromsci/bmw070 [doi]
PST - ppublish
SO  - J Chromatogr Sci. 2016 Sep;54(8):1277-81. doi: 10.1093/chromsci/bmw070. Epub 2016 
      Jun 3.