Abstract
The use of electronic cigarettes (e-cigarettes) is a growing trend in population. E-cigarettes are evolving at a rapid rate with variety of battery powered devices and combustible nicotine refills such as e-liquids. In contrast to conventional cigarettes which are studied well for their toxicity and health effects, long-term clinical data on e-cigarettes are not available yet. Therefore, safety of e-cigarettes is still a major concern. Although the Food and Drug Administration (FDA) has recently started regulating e-cigarette products, no limits on nicotine and other ingredients in such products have been proposed. Considering the regulatory requirements, it is critical that reliable and standardized analytical methods for analyzing nicotine and other ingredients in e-cigarette products such as e-liquids are available. Here, we are reporting a fully validated high-performance liquid chromatography (HPLC) method based on nicotine peak purity for accurately quantifying nicotine in various e-liquids. The method has been validated as per ICH Q2(R1) and USP <1225> guidelines. The method is specific, precise, accurate, and linear to analyze nicotine in e-liquids with 1 to >50 mg/mL of nicotine. Additionally, the method has been proven robust and flexible for parameters such as change in flow rate, column oven temperature, and organic phase composition, which proves applicability of the method over wide variety of e-liquids in market.
Highlights
Academic Editor: Josep Esteve-Romero e use of electronic cigarettes (e-cigarettes) is a growing trend in population
We are reporting a fully validated high-performance liquid chromatography (HPLC) method based on nicotine peak purity for accurately quantifying nicotine in various e-liquids. e method has been validated as per ICH Q2(R1) and USP guidelines. e method is specific, precise, accurate, and linear to analyze nicotine in e-liquids with 1 to >50 mg/mL of nicotine
We report a standardized and alternative analytical HPLC method for quantification of nicotine in e-liquids of various flavors
Summary
Academic Editor: Josep Esteve-Romero e use of electronic cigarettes (e-cigarettes) is a growing trend in population. Effective from August 8, 2016, all products meeting the statutory definition of tobacco products as per Tobacco Control Act are subject to regulations by Food and Drug Administration [5] Such products include e-cigarettes and e-liquids [5]. E-liquids are subject to FDA regulations, guidelines and permissible limits of nicotine and other ingredients of e-liquids have not been finalized yet due to several reasons such as lack of definitive and long-term clinical data, assessment of safety claims about e-cigarettes [6,7,8], and standardized analytical methods [9].
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