Gholap Vinit V, Kosmider Leon, Halquist Matthew S
Department of Pharmaceutics, School of Pharmacy, Virginia Commonwealth University, Richmond, VA 23298, USA.
Center for the Study of Tobacco Products, Virginia Commonwealth University, Richmond, VA 23298, USA.
J Anal Methods Chem. 2018 Aug 9;2018:1720375. doi: 10.1155/2018/1720375. eCollection 2018.
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.
电子烟的使用在人群中呈增长趋势。电子烟正以快速的速度发展，出现了各种电池供电设备以及诸如电子烟液等可燃尼古丁补充装。与传统香烟相比，传统香烟的毒性和健康影响已得到充分研究，但电子烟的长期临床数据尚未可得。因此，电子烟的安全性仍是一个主要关注点。尽管美国食品药品监督管理局（FDA）最近已开始对电子烟产品进行监管，但尚未对这类产品中的尼古丁及其他成分提出限量规定。考虑到监管要求，拥有可靠且标准化的分析方法来分析电子烟产品（如电子烟液）中的尼古丁及其他成分至关重要。在此，我们报告一种基于尼古丁峰纯度的经过全面验证的高效液相色谱（HPLC）方法，用于准确量化各种电子烟液中的尼古丁。该方法已按照国际人用药品注册技术协调会（ICH）Q2(R1)和美国药典<1225>指南进行了验证。该方法具有特异性、精密度、准确性，并且对于尼古丁含量为1至>50 mg/mL的电子烟液中的尼古丁分析具有线性关系。此外，该方法已被证明对于流速、柱温箱温度和有机相组成等参数具有稳健性和灵活性，这证明了该方法在市场上各种电子烟液中的适用性。
