title: Rapid determination of cocamidopropyl betaine impurities in cosmetic products by core-shell hydrophilic interaction liquid chromatography-tandem mass spectrometry.
abstract: Cocamidopropyl betaine (CAPB) is a common surfactant widely used in personal care products. Dimethylaminopropylamine (DMAPA) and lauramidopropyldimethylamine (LAPDMA) are two chemicals present as impurities in CAPB and have been reported as skin sensitizers. A rapid and sensitive ultra-high performance liquid chromatography-tandem mass spectrometry (UHPLC-MS/MS) method, using a core shell hydrophilic interaction liquid chromatography (HILIC) column, has been developed to quantify DMAPA and LAPDMA in cosmetic products. Corresponding stable isotopically labeled analogues of the above native compounds were used as internal standards to compensate for matrix effect and for loss of recovery. Each sample was first screened to determine whether the sample needed to be diluted to minimize matrix effects as well as to fit the calibration range. The concept of matrix effect factor (MEF) was introduced to quantitatively evaluate each sample with a unique matrix using the internal standards. Recoveries at three spiking levels of low, medium, and high concentrations ranged from 98.4 to 112% with RSDs less than 5%. This method has been validated and is the first UHPLC-MS/MS method, which uses core shell HILIC column and stable isotopically labeled internal standards to simultaneously determine these two CAPB impurities in cosmetic products.
authors.affiliation: U.S. Food and Drug Administration, Office of Regulatory Science, CFSAN/HFS-717, 5001 Campus Dr., College Park, MD 20740-3835, USA. Electronic address: wanggperry@gmail.com.
authors.forename: Perry G
authors.initials: PG
authors.lastname: Wang
authors.affiliation: U.S. Food and Drug Administration, Office of Regulatory Science, CFSAN/HFS-717, 5001 Campus Dr., College Park, MD 20740-3835, USA.
authors.forename: Wanlong
authors.initials: W
authors.lastname: Zhou
mesh_terms: D001622:Betaine / Q000031:analogs & derivatives* / Q000032:analysis; D002851:Chromatography, High Pressure Liquid / Q000379:methods; D003358:Cosmetics / Q000737:chemistry*; D003959:Diamines; D057927:Hydrophobic and Hydrophilic Interactions; D007850:Lauric Acids / Q000032:analysis*; D011437:Propylamines / Q000032:analysis*; D013501:Surface-Active Agents / Q000032:analysis*; D053719:Tandem Mass Spectrometry / Q000379:methods
chemical_list: D003358:Cosmetics; D003959:Diamines; D007850:Lauric Acids; D011437:Propylamines; D013501:Surface-Active Agents; C000612984:lauramidopropyldimethylamine; D001622:Betaine; C077055:cocamidopropyl betaine; C012928:3-dimethylaminopropylamine
keywords: Allergy; Cosmetics; Dimethylaminopropylamine; HILIC; Lauramidopropyldimethylamine; MS/MS; Matrix effects; Sensitizers