Determination of nicotine, eugenol, menthol and aerosol formers in tobacco products and materials
The purpose of this study was to validate a unique method that simultaneously determines the concentration of nicotine, eugenol, menthol, and glycerin in Reduced-Risk Products tobacco products, and menthol and triacetin in materials. Analytes are extracted from tobacco products (cast leaf, cast leaf containing cloves, tobacco plug, and tobacco powder) and materials (filter, mentholated filter, and mentholated inner liner) using methanol containing 1,3-butanediol as internal standard and analysed using gas chromatography equipped with a flame ionisation detector (GC-FID). Results were reported as percent dry-weight-basis (calculation performed considering water content measured by Karl Fisher titrator) for tobacco products and percent by weight, milligram per filter, or milligram per cm for materials.
Linearity was demonstrated for all compounds (R2 >0.995). The recoveries ranged between 90-107 % for concentrations in mg/mL and 80-110 % for concentrations in µg/mL for all targeted compounds in the tested matrices. In tobacco products, coefficient of variation (CV) of repeatability ranges between 0.52-2.06 % for nicotine, 0.91-2.25 % for glycerin, 0.72-3.62 % for eugenol, and 0.63-0.94 % for menthol. CV of intermediate precision ranges between 0.68-9.18 % for nicotine, 1.80-4.14 % for glycerin, 1.81-6.84 % for eugenol, and 2.07-9.59 % for menthol. In materials, CVs of repeatability of 8.98-17.85 % for menthol and 2.04-3.34 % for triacetin were obtained. CV for intermediate precision ranges between 8.98-18.35 % for menthol and 3.91-6.45 % for triacetin. Higher CVs for materials were obtained but mainly attributed to product variability.
The method was validated according to ICH guidelines, and validation results showed to be selective, precise, and accurate. A linear relationship was demonstrated over the tested concentration range.
 Reduced-Risk Products (RRPs) is the term used to refer to products that present, are likely to present, or have the potential to present less risk of harm to smokers who switch to these products versus continued smoking.