A LC-QTOF Method for the Determination of PEGDE Residues in Dermal Fillers

• Published in: Gels Vol. 9; no. 5; p. 409
• Main Authors: Alonci, Giuseppe, Boussard, Anna, Savona, Martina, Cordella, Fabiana, Angelici, Gaetano, Mocchi, Roberto, Sommatis, Sabrina, Monticelli, Damiano
• Format: Journal Article
• Language: English
• Published: Switzerland MDPI AG 13.05.2023; MDPI
• Subjects: Calibration; crosslinkers; Crosslinking; Dermal fillers; Ethylene glycol; Fillers; High performance liquid chromatography; high-resolution mass spectrometry; HPLC; Hyaluronic acid; Hydrogels; Instrument industry; Mass spectrometry; Methods; Molecular weight; Polyethylene glycol; Protocol; QTOF; Reference materials; Residues; Rheological properties; Rheology; Scientific imaging; Skin care products; validation; Viscoelasticity; United States; high-resolution mass spectrometry; crosslinkers; hydrogels; QTOF; HPLC; validation; dermal fillers; hyaluronic acid
• ISSN: 2310-2861; 2310-2861
• DOI: 10.3390/gels9050409

Hyaluronic acid is one of the most important ingredients in dermal fillers, where it is often cross-linked to gain more favorable rheological properties and to improve the implant duration. Poly(ethylene glycol) diglycidyl ether (PEGDE) has been recently introduced as a crosslinker because of its very similar chemical reactivity with the most-used crosslinker BDDE, while giving special rheological properties. Monitoring the amount of the crosslinker residues in the final device is always necessary, but in the case of PEGDE, no methods are available in literature. Here, we present an HPLC-QTOF method, validated according to the guidelines of the International Council on Harmonization, which enables the efficient routine examination of the PEGDE content in HA hydrogels.