Determination study of α-dicarbonyl degradation products in icodextrin peritoneal dialysis solution by o-phenylenediamine derivatization HPLC-MS/MS
10.11665/j.issn.1000-5048.2025080602
- VernacularTitle:艾考糊精腹膜透析液中的α-双羰基类降解产物邻苯二胺衍生化HPLC-MS/MS测定研究
- Author:
Xiaomin FAN
1
;
Lina ZHANG
;
Feng ZHENG
Author Information
1. 中国药科大学药学院, 南京211198
- Publication Type:Journal Article 期刊文章
- Keywords:
icodextrin peritoneal dialysis solution;
α-dicarbonyl degradation products;
o-phenylenediamine;
derivatization;
HPLC-MS/MS
- From:
Journal of China Pharmaceutical University
2026;57(2):233-239
- CountryChina
- Language:Chinese
-
Abstract:
Icodextrin peritoneal dialysis solution may produce cytotoxic α-dicarbonyl degradation products during heat sterilization, which must be monitored and controlled. The study established an o-phenylenediamine (OPD) derivatization HPLC-MS/MS method for the detection of these degradation products, enabling qualitative and quantitative analysis of α-dicarbonyl degradation products in icodextrin peritoneal dialysis solution. The results indicated that the main α-dicarbonyl degradation products in icodextrin peritoneal dialysis solution are 3-deoxyglucosone (3-DG), 3-deoxygalactosone (3-DGal), 4-deoxyglucosone (4-DG), and 3,4-dideoxyglucosone-3-ene (3,4-DGE), along with two monocarbonyl degradation products, furfural and 5-hydroxymethylfurfural. The quantitative method for 3-DG, 3-DGal, 3,4-DGE and their structural analog, glucosone, was validated. 3-DG, 3-DGal, and glucosone exhibited good linear relationships within the range of 5-150 ng/mL, while 3,4-DGE showed good linearity in the range of 1-150 ng/mL. The spiked recovery rates for all compounds were between 86.8% and 100.0%. The detection limits for glucosone, 3-DG, and 3-DGal were approximately 2.4 ng/mL, and approximately 0.5 ng/mL for 3,4-DGE. The method established in this study can accurately determine α-dicarbonyl degradation products in icodextrin peritoneal dialysis solution, providing an important basis for the quality control.
