STANDARDIZATION OF E-CIGARETTE RESEARCH: ADDRESSING THE ANALYSIS OF TOTAL NICOTINE AND FREE BASE NICOTINE IN E-CIGARETTES
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Doctor of Philosophy
Electronic cigarettes (e-cigarettes) are one of the major sources of exposure to nicotine, an addictive chemical. Since 2016, the Food and Drug Administration (FDA) has started regulating these products under the Tobacco Control Act yet, specifications about the nicotine content in these products have not been established. In e-cigarettes, nicotine concentration ranges from 0 to >50mg/mL. Additionally, several e-cigarette related parameters have been identified which can affect nicotine delivery to users. Of these factors, nicotine forms (protonated and free base) have been found to play a significant role in nicotine absorption profiles yet, a limited and contradictory research is available on them. One of the challenges in the analysis of these products is lack of standardized approaches and regulatory guidelines in the research.
The primary goal of this study is to provide such standardization approaches for the analysis of total nicotine (free base + protonated nicotine) and free base nicotine in both pre and post vaporization of e-cigarettes. The study proposes HPLC analytical method as one of the standardized approaches for analysis of total nicotine in e-cigarettes. Additionally, based on the scope and limitations of different methods for free base nicotine determination, the study proposes dilution approach with Henderson Hasselbalch method as a biorelevant approach for free base nicotine analysis. Further, the study also describes the standardized method for e-cigarette aerosol generation and analysis for total and free base nicotine determination. Lastly, the study also describes the e-cigarette and vaping related variables affecting the free base nicotine yield.
The results of the study would serve as guidelines for the clinical studies aimed at measuring nicotine absorption profiles under various vaping conditions. Additionally, the study can serve as guidelines for regulatory agencies for developing standardized approaches in the e-cigarette research for better regulations of these products.
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Available for download on Sunday, January 11, 2026
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