title: General approach for the chromatographic determination of 2-hydroxypyridine-1-oxide (HOPO) in pharmaceutically relevant materials utilizing a high pH ion-pairing strategy.
abstract: 2-Hydroxypyridine-1-oxide (HOPO) is utilized in the pharmaceutical sector to facilitate the formation of amide bonds. This present work describes the development of a HPLC high pH ion-pairing method for the trace analysis of HOPO in pharmaceutically relevant materials. Several method development aspects are discussed and the application of this method to several late-stage programs is presented.
authors.affiliation: Associate Principle Scientist, Merck Manufacturing Division: Analytical Development and Commercialization - Active Pharmaceutical Ingredient, Rahway, NJ, USA. Electronic address: justin.denton@merck.com.
authors.forename: Justin R
authors.initials: JR
authors.lastname: Denton
authors.affiliation: Associate Principle Scientist, Merck Manufacturing Division: Analytical Development and Commercialization - Active Pharmaceutical Ingredient, Rahway, NJ, USA. Electronic address: scott_thomas@merck.com.
authors.forename: Scott
authors.initials: S
authors.lastname: Thomas
authors.affiliation: Director Chemistry, Merck Research Laboratories: Analytical Chemistry, Rahway, NJ, USA. Electronic address: bing.mao@merck.com.
authors.forename: Bing
authors.initials: B
authors.lastname: Mao
mesh_terms: D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D003497:Cyclic N-Oxides / Q000032:analysis*; D004340:Drug Contamination; D057230:Limit of Detection; D015394:Molecular Structure; D004364:Pharmaceutical Preparations / Q000032:analysis*; D011725:Pyridines / Q000032:analysis*; D013237:Stereoisomerism
chemical_list: C547041:2-hydroxypyridine-N-oxide; D003497:Cyclic N-Oxides; D004364:Pharmaceutical Preparations; D011725:Pyridines