Safety Monitoring

Determination of anti-obesity drugs illegally added in health care products by TLC-NIRS*

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  • 1. Ankang Inspection and Detection Center of Food and Drug Control, Ankang 725000, China;
    2. Department of Chinese Medicine, Beijing University of Chinese Medicine, Beijing 100029, China

Received date: 2022-09-28

  Online published: 2024-06-25

Abstract

Objective: To establish the detection method of illegally-added anti-obesity drugs by thin layer chromatography (TLC) combined with near-infrared spectroscopy (NIRS), for the rapid qualitative and quantitative analysis of drugs illegally added in health care products. Methods: With the content of chemical drugs in health care products determined by HPLC method as a reference value. Using chloroform-methanol-formic acid (24∶2∶1) as the developing solvent for illegally-added chemical drugs by TLC, the TLC plate was checked and marked under ultraviolet lamp. The NIR spectra of chemical component spots on TLC were collected by NIRS. The rapid qualitative and quantitative model of chemical drugs was established and validated by using the partial least squares regression analysis (PLS) combined with cross validation method. Results: The established HPLC analysis method was accurate with good separation and wide linear range. The established TLC-NIRS analysis models of phenolphthalein, furosemide and sibutramine hydrochloride was specific with wide linear range and good prediction results. The correlation coefficients (R2), the root mean square errors of calibration validation (RMSECV) and the root mean square errors of prediction (RMSEP) were 0.980, 0.085 and 0.083; 0.922, 0.106 and 0.086; 0.936, 0.091 and 0.085, respectively. Ten batches of anti-obesity products were detected by TLC-NIRS model, and the average relative deviations of the contents of phenolphthalein, furosemide and sibutramine hydrochloride of predicted were 1.75%, 1.26% and 1.19%, respectively. Conclusion: The proposed TLC-NIRS analysis models are universal and simple, and can be used for rapid determination of the above chemical components in anti-obesity products, which provide the ideas for rapid determination of illegally-added drugs in health care products.

Cite this article

ZHANG Li-jun, ZHANG Xin-yue, ZHANG Zhuan-ping, LI Xiao-an, XU Gui-xin, TAN Hua-sen, WU Chun-yan, WU You-duo . Determination of anti-obesity drugs illegally added in health care products by TLC-NIRS*[J]. Chinese Journal of Pharmaceutical Analysis, 2022 , 42(11) : 1961 -1971 . DOI: 10.16155/j.0254-1793.2022.11.13

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