Website: https://vjfc.nifc.gov.vn/
Website: https://vjfc.nifc.gov.vn/
The illegal adulteration of weight loss products using pharmaceutical substances such as sibutramine, furosemide, and phenolphthalein poses a serious threat to public health. This study aimed to develop and validate a method for the simultaneous quantification of these compounds in weight loss dietary supplements using high-performance liquid chromatography with photodiode array detection (HPLC-PDA). The optimized method employed an InertSUSTAIN Phenyl column (250 mm × 4.6 mm, 5 µm), with a mobile phase of acetonitrile and 0.5% phosphoric acid (45% : 55%), a flow rate of 1 mL/min, and detection at 225 nm. Samples were extracted using 96% ethanol with a simple preparation procedure. The method was validated according to AOAC guidelines, including selectivity, linearity, accuracy, precision, limits of detection (LOD), limits of quantification (LOQ), and dilution integrity. The method showed excellent linearity (R² > 0.998), acceptable recoveries (95–103%), and low LODs and LOQs (0.161–0.758 µg/mL). Application of the method to 19 commercial weight loss products revealed 4 samples containing sibutramine and 2 samples containing phenolphthalein. This method is suitable for routine use in food control laboratories to ensure the safety of weight loss products.
sibutramine, phenolphthalein, furosemide, HPLC-PDA, weight loss products.
[1]. A. Okunogbe, R. Nugent, G. Spencer, J. Powis, J. Ralston, and J. Wilding, “Economic impacts of overweight and obesity: current and future estimates for 161 countries,” BMJ Global Health, vol. 7, no. 9, 2022.
[2]. C. J. L. Murray, A. Y. Aravkin, P. Zheng, et al., “Global Burden of 87 Risk Factors in 204 Countries and territories, 1990–2019: a Systematic Analysis for the Global Burden of Disease Study 2019,” The Lancet, vol. 396, no. 10258, pp. 1223–1249, 2020.
[3]. European Medicines Agency, “European Medicines Agency recommends suspension of marketing authorisations for sibutramine,” Jan. 21, 2010. Accessed: Jun. 19, 2025. [Online]. Available: https://www.ema.europa.eu/en/news-events/press-releases/european-medicines-agency-recommends-suspension-marketing-authorisations-sibutramine.
[4]. U.S. Food and Drug Administration (FDA), “FDA announces the manufacturer’s withdrawal of Meridia from the market,” Oct. 8, 2010. Accessed: Jun. 19, 2025. [Online]. Available Available: https://www.fda.gov/news-events/press-announcements/fda-announces-manufacturers-withdrawal-meridia-market.
[5]. U.S. Food and Drug Administration (FDA), “FDA Public Health Advisory: Laxative Drug Products Containing Phenolphthalein,” Dec. 17, 1997. Accessed: Jun. 19, 2025]. [Online]. Available: https://wayback.archive-it.org/7993/20170112104523/http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm106199.htm.
[6]. Ministry of Health, Circular No. 10/2021/TT-BYT stipulating the List of Substances Prohibited from Use in the Production and Trading of Health Supplements, issued on June 30, 2021 [in Vietnamese].
[7]. Government, Decree No. 54/2017/ND-CP detailing a number of articles and implementing measures of the Law on Pharmacy, issued on May 8, 2017. [in Vietnamese]
[8]. Le Dinh Chi, Le Thi Hong Hao, “Detection of illegally present sibutramine in weight loss functional foods using high-performance liquid chromatography,” Vietnam Journal of Science and Technology, no. 4B, pp. 60–64, 2015 [in Vietnamese].
[9]. Nguyen Thai Ngoc Mai, Nguyen Thi Ngoc Van, “Development of a simultaneous quantification procedure for illegally mixed sibutramine and phenolphthalein in weight loss functional foods using HPLC-PDA,” Can Tho Journal of Medicine and Pharmacy, no. 29, pp. 171–178, 2023 [in Vietnamese].
[10]. Cao Cong Khanh, Nguyen Tuong Vy, Hoang Quynh Trang, “Study on the simultaneous determination procedure of sibutramine, furosemide, dexamethasone, and piroxicam in functional foods using HPLC technique,” Journal of Pharmacy, vol. 53, no. 5, pp. 40–44, 2013 [in Vietnamese].
[11]. Duong Thi Mai Hoa, Pham Thi Ngoc Mai, Hoang Quoc Anh, Cao Cong Khanh, Nguyen Thi Hong Ngoc, Mac Thi Thanh Hoa, Tran Hung Son, Nguyen Thi Van Anh, Le Thi Hong Hao, “Simultaneous determination of sibutramine and its derivatives in weight loss dietary supplements by LC-MS/MS)”, Vietnamese Journal of Food Control, vol. 3, no. 2, pp. 104 – 114, 2020.
[12]. Truong Van Than, Nguyen Thanh Duy, Ly Tuan Kiet, Hoang Ngoc Vinh, Chu Van Hai, “Determination of sibutramine and phenolphthalein in weightloss tea, coffee, and milk by UltraPerformance Liquid Chromatography Mass Spectrometry UPLCMS/MS”, Vietnamese Journal of Food Control, vol. 2, no. 4, pp. 42 – 48, 2019 [in Vietnamese].
[13]. Phattanawasin P, Sotanaphun U, Sukwattanasinit T, Akkarawaranthorn J, Kitchaiya S., “Quantitative determination of sibutramine in adulterated herbal slimming formulations by TLC-image analysis method”, Forensic Sciencce Intnational, vol. 219, no. 1-3, pp. 96-100, 2012.
[14]. Government, Decree No. 15/2018/ND-CP detailing the implementation of a number of articles of the Law on Food Safety, issued on February 2, 2018 [in Vietnamese].
[15]. AOAC International, “Appendix K - Guidelines for Dietary Supplements and Botanical”, Official Methods of Analysis of AOAC INTERNATIONAL, 2023.