Highly sensitive spectrofluorimetric method for the determination of the genotoxic methylglyoxal in glycerol-containing pharmaceuticals and dietary supplements

Luminescence. 2023 Jan;38(1):39-46. doi: 10.1002/bio.4419. Epub 2022 Dec 19.

Abstract

Methylglyoxal (MGO) is a genotoxic α-dicarbonyl compound. Recently, it was found to be formed in glycerol preparations during storage through auto-oxidation. A simple fluorimetric determination of the carcinogenic degradation product of glycerol, MGO, was developed and validated. The proposed method is based on the derivatization of MGO with 4-carbomethoxybenzaldehyde (CMBA) and ammonium acetate to yield a fluorescent imidazole derivative that can be measured at 415 nm after excitation at 322 nm. The optimized conditions were determined to be 0.2 M CMBA, 1.0 M ammonium acetate and a reaction time of 40 min at 90°C using ethanol as diluting solvent. The linear range was 10.0-200.0 ng/ml. Detection and quantification limits were 2.22 and 6.72 ng/ml, respectively. The proposed method was validated according to International Council for Harmonisation (ICH) guidelines and compared with the reported method and no significant difference was found. It was successfully applied for the determination of MGO in six different glycerol-containing pharmaceutical preparations and dietary supplements.

Keywords: genotoxic impurities; glycerol; methylglyoxal; spectrofluorimetric.

MeSH terms

  • Dietary Supplements
  • Glycerol*
  • Magnesium Oxide
  • Pharmaceutical Preparations
  • Pyruvaldehyde*
  • Spectrometry, Fluorescence / methods

Substances

  • ammonium acetate
  • Glycerol
  • Pyruvaldehyde
  • Magnesium Oxide
  • Pharmaceutical Preparations