title: Quantification of 5-HMF and dextrose in commercial aqueous dextrose solutions.
abstract: 5-Hydroxymethylfurfural (5-HMF) is the major thermal decomposition product formed in aqueous dextrose solutions during sterilization and upon storage. Current compendial tests employ a spectrophotometric assay for 5-HMF and a separate assay based on optical rotation for dextrose. Efforts herein focused on identification of approaches to simultaneously quantify both 5-HMF and dextrose in aqueous solutions. Initial studies employed anion exchange chromatography with pulsed amperometric detection (PAD). These studies showed that the low anion exchange column loading capacity and concentration mismatch of dextrose and 5-HMF in typical commercial solutions makes simultaneous quantitation impractical at a single sample concentration. However, mixed modes of detection for each analyte using refractive index (RI) detection for dextrose and UV detection for 5-HMF proved viable for simultaneous quantitation. The performance of both approaches was evaluated and extremely high sensitivity for 5-HMF demonstrated (30-50 ppb). The formation of 5-HMF upon the forced thermal decomposition of dextrose was monitored and compared with results from the USP spectrophotometric assay.
authors.affiliation: Pharmaceutical Research and Development, Merck Research Laboratories, Merck & Co., Inc., West Point, PA 19486, USA.
authors.forename: Hui
authors.initials: H
authors.lastname: Xu
authors.forename: Allen C
authors.initials: AC
authors.lastname: Templeton
authors.forename: Robert A
authors.initials: RA
authors.lastname: Reed
mesh_terms: D002851:Chromatography, High Pressure Liquid; D002852:Chromatography, Ion Exchange; D004355:Drug Stability; D005662:Furaldehyde / Q000031:analogs & derivatives* / Q000032:analysis*; D005947:Glucose / Q000032:analysis*; D006358:Hot Temperature; D012031:Refractometry; D015203:Reproducibility of Results; D012996:Solutions; D013056:Spectrophotometry, Ultraviolet
chemical_list: D012996:Solutions; C008046:5-hydroxymethylfurfural; D005662:Furaldehyde; D005947:Glucose