Abstract
(1) Background: Despite the growing use of e-cigarettes, in most countries, there is no regulation covering manufacturing standards of the solution (‘e-liquid’), leading to concerns over the accuracy of labelling and stability of the products under a range of conditions. Following the United States (US) Food and Drug Administration (FDA) requirements for manufacture of e-liquids, we aimed to develop a simple high-performance liquid chromatography (HPLC) method to determine nicotine content in nicotine-containing e-liquids, even in the presence of degradation products; (2) Methods: We developed an HPLC method to quantify nicotine in the presence of the two major constituents of all e-liquids, glycerine and propylene glycol, and in the presence of degradation products; (3) Results: Our HPLC method performed strongly and was validated according to international guidelines. For the e-liquids tested, nicotine content levels were all higher than labelled (up to 117.9 ± 1.87% of the labelled content). While nicotine was shown to be unstable at 60 °C, it was stabilized at this temperature in the e-liquid formulations for up to 10 days; and (4) Conclusions: The HPLC method is suitable for adoption by laboratories to determine the actual content and stability of nicotine-containing products. The higher than labelled nicotine levels in e-liquids raises clinical and public health concerns.
Highlights
Electronic cigarettes (e-cigarettes) were first introduced in China in 2004 as a safe cigarette substitute [1,2]
We report a simple, economical, and rapid stability-indicating high-performance liquid chromatography (HPLC) method for the quantification of nicotine included within e-liquids
We developed and validated a stability-indicating HPLC method for the quantification of nicotine
Summary
Electronic cigarettes (e-cigarettes) were first introduced in China in 2004 as a safe cigarette substitute [1,2]. E-cigarettes comprise a battery and coil to heat and aerosolize a solution (‘e-liquid’). E-liquid is a solution of pure nicotine dissolved in propylene glycol, vegetable glycerine, and flavors [1]. Due to the presence of such simple constituents and lack of combustion in the process of aerosolization, e-cigarettes are considered a safer alternative to tobacco smoking [3]. A handful of clinical trials have found e-cigarettes to be modestly effective at helping smokers to quit with few reported adverse effects after several months use [5,6]. Various issues related to labelling and content accuracy have been reported in the literature. Some e-liquids labelled as containing no nicotine were found to have higher concentrations of nicotine [7,8,9].
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