Detection of dehalogenation impurities in organohalogenated pharmaceuticals by UHPLC-DAD-HRESIMS.
The presence of dehalogenated impurities is often observed in halogen-containing pharmaceuticals, and can present a difficult analytical challenge, as the chromatographic behavior of the halogenated drug and the hydrogen-containing analog can be quite similar. In this study we describe the chromatographic separation and unambiguous identification of dehalogenation impurities or associated isomers in organohalogenated pharmaceuticals using UHPLC with a pentafluorophenyl column coupled with diode-array and high resolution electrospray ionization mass spectrometry detection (UHPLC-DAD-HRESIMS).
Merck Research Laboratories, Rahway, NJ 07065, USA. Electronic address: erik.regalado@merck.com.
Erik L
EL
Regalado
Merck Research Laboratories, Rahway, NJ 07065, USA.
Renee K
RK
Dermenjian
Merck Research Laboratories, Rahway, NJ 07065, USA.
Leo A
LA
Joyce
Merck Research Laboratories, Rahway, NJ 07065, USA. Electronic address: christopher_welch@merck.com.
Christopher J
CJ
Welch
D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004340:Drug Contamination; D054879:Halogenation; D006219:Halogens / Q000737:chemistry*; D004364:Pharmaceutical Preparations / Q000737:chemistry*; D021241:Spectrometry, Mass, Electrospray Ionization / Q000379:methods*
D006219:Halogens; D004364:Pharmaceutical Preparations
Dehalogenation impurities; HRMS; Method development; Perfluorophenyl; UHPLC