A Rapid Screening Method for Sibutramine Hydrochloride in Natural Herbal Medicines and Dietary Supplements

Herbal weight loss drugs are becoming more widely used in the fight against obesity, but ineffective regulation of these products have resulted in harmful additives. These products may contain adulterants such as sibutramine hydrochloride that may result in serious adverse health events including de...

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Main Authors: Qi Liang, Yue Zhuang, Jun Ma, Jinyan Wang, Rui Feng, Ruisi He, Zhuoya Luo, Honghao Wang, Ruoting Zhan
Format: Article
Language:English
Published: Wiley 2021-01-01
Series:International Journal of Analytical Chemistry
Online Access:http://dx.doi.org/10.1155/2021/8889423
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author Qi Liang
Yue Zhuang
Jun Ma
Jinyan Wang
Rui Feng
Ruisi He
Zhuoya Luo
Honghao Wang
Ruoting Zhan
author_facet Qi Liang
Yue Zhuang
Jun Ma
Jinyan Wang
Rui Feng
Ruisi He
Zhuoya Luo
Honghao Wang
Ruoting Zhan
author_sort Qi Liang
collection DOAJ
description Herbal weight loss drugs are becoming more widely used in the fight against obesity, but ineffective regulation of these products have resulted in harmful additives. These products may contain adulterants such as sibutramine hydrochloride that may result in serious adverse health events including death. This work established a color precipitation reaction-based rapid screening method for illegal adulteration of sibutramine hydrochloride in natural herbal medicines (NHM) and dietary supplements (DS). While a variety of chromatography- and electrophoresis-based systems have been reported to measure this analyte, they generally suffer from high costs, complicated sample preparation, and a costly analytical infrastructure. In contrast, we present a simple, handheld kit to assay for sibutramine. The performance metrics of this tool include an average detection time of approximately 3 minutes, which is markedly shorter than conventional methods (HPLC or HPLC-MS, etc.), a detection limit of 0.1 mg per aliquot, and an accuracy of 99.02% (n = 820). More strikingly, the sensitivity is 100% (n = 278), and the specificity is 98.52% (n = 542). The rapid test kit developed from this screening method was evaluated by FDA. In summary, this screening method is a rapid, simple, and low-cost tool for the detection of sibutramine in NHM and DS with superior selectivity and sensitivity. For these reasons, this method is especially suitable for underdeveloped settings because it can be employed onsite without any instrumentation. In addition, this approach could rapidly exclude most of the negative samples to boost efficiency in large-scale samples assay. If necessary, positive samples can undergo further alternate testing methods to confirm the positive results of sibutramine hydrochloride content.
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spelling doaj-art-065f69394de94597810abcb735e36e202025-02-03T07:24:23ZengWileyInternational Journal of Analytical Chemistry1687-87601687-87792021-01-01202110.1155/2021/88894238889423A Rapid Screening Method for Sibutramine Hydrochloride in Natural Herbal Medicines and Dietary SupplementsQi Liang0Yue Zhuang1Jun Ma2Jinyan Wang3Rui Feng4Ruisi He5Zhuoya Luo6Honghao Wang7Ruoting Zhan8Guangdong Institute for Drug Control, Guangzhou, ChinaGuangdong Institute for Drug Control, Guangzhou, ChinaGuangdong Institute for Drug Control, Guangzhou, ChinaGuangdong Institute for Drug Control, Guangzhou, ChinaResearch Center of Chinese Herbal Resource Science and Engineering, Guangzhou University of Chinese Medicine, Guangzhou, ChinaSchool of Pharmaceutical Sciences, Sun Yat-Sen University, Guangzhou, ChinaGuangdong Institute for Drug Control, Guangzhou, ChinaMarket Regulation Administration of Guangdong, Guangzhou, ChinaSchool of Chinese Materia Medica, Ministry of Education, Key Laboratory of Chinese Medicinal Resource from Lingnan, Guangzhou University of Chinese Medicine, Guangzhou, ChinaHerbal weight loss drugs are becoming more widely used in the fight against obesity, but ineffective regulation of these products have resulted in harmful additives. These products may contain adulterants such as sibutramine hydrochloride that may result in serious adverse health events including death. This work established a color precipitation reaction-based rapid screening method for illegal adulteration of sibutramine hydrochloride in natural herbal medicines (NHM) and dietary supplements (DS). While a variety of chromatography- and electrophoresis-based systems have been reported to measure this analyte, they generally suffer from high costs, complicated sample preparation, and a costly analytical infrastructure. In contrast, we present a simple, handheld kit to assay for sibutramine. The performance metrics of this tool include an average detection time of approximately 3 minutes, which is markedly shorter than conventional methods (HPLC or HPLC-MS, etc.), a detection limit of 0.1 mg per aliquot, and an accuracy of 99.02% (n = 820). More strikingly, the sensitivity is 100% (n = 278), and the specificity is 98.52% (n = 542). The rapid test kit developed from this screening method was evaluated by FDA. In summary, this screening method is a rapid, simple, and low-cost tool for the detection of sibutramine in NHM and DS with superior selectivity and sensitivity. For these reasons, this method is especially suitable for underdeveloped settings because it can be employed onsite without any instrumentation. In addition, this approach could rapidly exclude most of the negative samples to boost efficiency in large-scale samples assay. If necessary, positive samples can undergo further alternate testing methods to confirm the positive results of sibutramine hydrochloride content.http://dx.doi.org/10.1155/2021/8889423
spellingShingle Qi Liang
Yue Zhuang
Jun Ma
Jinyan Wang
Rui Feng
Ruisi He
Zhuoya Luo
Honghao Wang
Ruoting Zhan
A Rapid Screening Method for Sibutramine Hydrochloride in Natural Herbal Medicines and Dietary Supplements
International Journal of Analytical Chemistry
title A Rapid Screening Method for Sibutramine Hydrochloride in Natural Herbal Medicines and Dietary Supplements
title_full A Rapid Screening Method for Sibutramine Hydrochloride in Natural Herbal Medicines and Dietary Supplements
title_fullStr A Rapid Screening Method for Sibutramine Hydrochloride in Natural Herbal Medicines and Dietary Supplements
title_full_unstemmed A Rapid Screening Method for Sibutramine Hydrochloride in Natural Herbal Medicines and Dietary Supplements
title_short A Rapid Screening Method for Sibutramine Hydrochloride in Natural Herbal Medicines and Dietary Supplements
title_sort rapid screening method for sibutramine hydrochloride in natural herbal medicines and dietary supplements
url http://dx.doi.org/10.1155/2021/8889423
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