Development and Validation of an analytical method for the Identification and Quantification of Ceteareth in hair cosmetic formulations by High-Performance Liquid Chromatography with Refractive Index Detector (HPLC-RID)
DOI:
https://doi.org/10.33448/rsd-v15i5.51109Keywords:
Hair Cosmetics, Surfactant, Refractive Index, Fouling.Abstract
In Brazil, cosmetic products classified as Grade 1 are considered to pose low health risk, however, between 2022 and 2023, more than 700 cases of serious adverse events associated with the use of hair styling ointments were reported. During the investigations, the emulsifying agent Ceteareth was identified among the formulation components to be subjected to analytical testing in order to elucidate the possible causes of these adverse effects. The aim of this study was to propose the development and validation of a high-performance liquid chromatography method with refractive index detection (HPLC-RID) for the identification and quantification of Ceteareth in these cosmetic formulations. Initially, an ion-exchange column was used for method development; however, after identifying the occurrence of fouling caused by pore blockage, it became necessary to employ a size-exclusion chromatography column, which showed better performance and was therefore selected for the validation tests. The results demonstrated satisfactory performance regarding the evaluated analytical validation parameters, proving the method to be selective, linear, precise, and accurate, according to the criteria established by RDC No. 166/2017 of Anvisa and the DOQ-CGCRE-008 Guidance Document issued by Inmetro. Therefore, it was possible to conclude that the proposed method presents adequate applicability for the analysis of Ceteareth in hair styling ointments, in addition to contributing to the elucidation of serious adverse event cases.
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Copyright (c) 2026 Gabriela Teixeira de Lima, Adriana Sant’Ana da Silva, Lauro de Sena Laurentino, Fellipe Campos da Fonseca, Jéssica da Silva Pinheiro de Carvalho Monteiro, Ana Lúcia Ribeiro de Barros, Carlos Cândido Santos Júnior
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