A Stability Indicating HPLC Method to Determine Actual Content and Stability of Nicotine within Electronic Cigarette Liquids.

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 it 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.