不同无烟烟草基质中尼古丁含量的反相高效液相色谱分析:印度商业和地方产品的比较研究

IF 2.7 4区 医学 Q2 PHARMACOLOGY & PHARMACY
Ashu Rathi, Arbab Husain, Afreen Khanam, Mohd Farhan, Mohammad Aatif, Rajeev Singh Raghuvanshi, Gaurav Pratap Singh, Anirudh Malik
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引用次数: 0

摘要

目的在印度,由于对无烟烟草产品的毒理学风险和潜在成瘾性认识不足,无烟烟草产品迅速扩散。本研究建立了反相高效液相色谱(RP-HPLC)方法,用于烟草、鼻烟、Pan masala、Zarda和Supari等无烟烟草制品中尼古丁的准确定量。该方法简便、准确、稳定、分析快速,可精确测定微克/克(ppm)水平的尼古丁浓度。分析了来自印度五个邦(北方邦、西孟加拉邦、海得拉巴、阿萨姆邦和古吉拉特邦)的各种商业和当地采购的无烟烟草样本。方法采用Inertsil C18色谱柱,流动相为1.1%三乙胺(TEA)缓冲液和乙腈(75:25,pH 7.0),流速为1.0 mL/min,达到最佳分离效果。在254 nm处进行紫外检测。方法按照ICH Q2(R1)指南进行验证。结果HPLC法测定烟碱峰纯度为99.62%。验证参数符合ICH指南,系统、方法和中间精密度RSD值分别为0.03%、0.18%和0.12%。平均回收率为99.18%,在2.5 ~ 150%范围内建立线性关系(R²= 0.9993)。尼龙和PVDF过滤器被认为适合于尼古丁分析。甲醇稀释剂在标准溶液中稳定20 h,在测试溶液中稳定12 h。强制降解研究揭示了尼古丁在酸性、碱性和氧化条件下的显著不稳定性。对84份无烟烟草样品的分析得出,西孟加拉邦的尼古丁浓度为24.0至55296.8µg/g,北方邦为17.2至35778.2µg/g,古吉拉特邦为56.3至2239.0µg/g,喜马偕尔邦为7239.0至22768.2µg/g,海得拉巴为52.2至27192.0µg/g。结论:对印度无烟烟草制品的定量分析显示,产品间尼古丁浓度存在显著差异。这些发现强调了与无烟烟草使用有关的潜在公共健康风险,特别是尼古丁的成瘾性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

RP-HPLC Analysis of Nicotine Content in Diverse Smokeless Tobacco Matrices: A Comparative Study of Commercial and Local Products from India

RP-HPLC Analysis of Nicotine Content in Diverse Smokeless Tobacco Matrices: A Comparative Study of Commercial and Local Products from India

Objective

The rapid proliferation of smokeless tobacco (SLT) products in India has occurred without sufficient awareness of their toxicological risks and addiction potential. This study developed and validated a robust reversed-phase high-performance liquid chromatography (RP-HPLC) method for the accurate quantification of nicotine in smokeless tobacco products (SLT) includes Tobacco, Snus, Pan masala, Zarda and Supari. The method was optimized for simplicity, accuracy, stability, and rapid analysis, enabling precise determination of nicotine concentrations at microgram-per-gram (ppm) levels. Diverse commercial and locally sourced smokeless tobacco samples from five Indian states (Uttar Pradesh, West Bengal, Hyderabad, Assam and Gujrat) were analysed.

Method

Optimal chromatographic separation was achieved using an Inertsil C18 column with an isocratic mobile phase of 1.1% triethylamine (TEA) buffer and acetonitrile (75:25, pH 7.0) at a flow rate of 1.0 mL/min. UV detection was performed at 254 nm. The method was validated according to ICH Q2(R1) guidelines.

Results

The developed HPLC assay demonstrated a nicotine peak purity of 99.62%. Validation parameters met ICH guidelines, with system, method, and intermediate precision RSD values of 0.03%, 0.18%, and 0.12%, respectively. Mean recovery was 99.18%, and linearity was established over a 2.5–150% range (R² = 0.9993). Nylon and PVDF filters were deemed suitable for nicotine analysis. Methanol diluent stability was confirmed for 20 h for standard solutions and 12 h for test solutions. Forced degradation studies revealed significant nicotine instability under acidic, basic, and oxidative conditions. Analysis of 84 smokeless tobacco samples yielded nicotine concentrations ranging from 24.0 to 55296.8 µg/g in West Bengal, 17.2 to 35778.2 µg/g in Uttar Pradesh, 56.3 to 2239.0 µg/g in Gujarat, 7239.0 to 22768.2 µg/g in Himachal Pradesh, and 52.2 to 27192.0 µg/g in Hyderabad.

Conclusion

Quantitative analysis of smokeless tobacco products across India revealed substantial inter-product variability in nicotine concentrations. These findings highlight the potential public health risks associated with smokeless tobacco use, particularly concerning the addictive nature of nicotine.

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来源期刊
Journal of Pharmaceutical Innovation
Journal of Pharmaceutical Innovation PHARMACOLOGY & PHARMACY-
CiteScore
3.70
自引率
3.80%
发文量
90
审稿时长
>12 weeks
期刊介绍: The Journal of Pharmaceutical Innovation (JPI), is an international, multidisciplinary peer-reviewed scientific journal dedicated to publishing high quality papers emphasizing innovative research and applied technologies within the pharmaceutical and biotechnology industries. JPI''s goal is to be the premier communication vehicle for the critical body of knowledge that is needed for scientific evolution and technical innovation, from R&D to market. Topics will fall under the following categories: Materials science, Product design, Process design, optimization, automation and control, Facilities; Information management, Regulatory policy and strategy, Supply chain developments , Education and professional development, Journal of Pharmaceutical Innovation publishes four issues a year.
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