Food and Drug Administration, Division of Pharmaceutical Analysis, 1114 Market St., St. Louis, MO 63101, United States.
J Pharm Biomed Anal. 2012 Dec;71:18-26. doi: 10.1016/j.jpba.2012.07.020. Epub 2012 Aug 6.
Ion mobility spectrometry (IMS) served as a rapid, qualitative screening tool for the analysis of adulterated weight-loss products. We have previously shown that sibutramine extracted into methanol from dietary supplements can be detected at low levels (2ng) using a portable IMS spectrometer, and have adapted a similar method for the analysis of additional weight-loss product adulterants. An FDA collaborative study helped to define the limits for fluoxetine with a limit of detection of 2ng. We also evaluated more readily available, less toxic extraction solvents and found isopropanol and water were comparable to methanol. Isopropanol was favored over water for two reasons: (1) water increases the analysis time and (2) aqueous solutions were more susceptible to pH change, which affected the detection of sibutramine. In addition to sibutamine and fluoxetine, we surveyed 11 weight-loss adulterants; bumetanide, fenfluramine, furosemide, orlistat, phenolphthalein, phentermine, phenytoin, rimonabant, sertraline and two sibutramine analogs, desmethylsibutramine and didesmethylsibutramine, using portable and benchtop ion mobility spectrometers. Out of these 13 active pharmaceutical ingredients (APIs), portable and benchtop ion mobility spectrometers were capable of screening products for 10 of these APIs. The developed procedure was applied to two weight-loss dietary supplements using both portable and benchtop instruments. One product contained didesmethylsibutramine while the other contained didesmethylsibutramine and phenolphthalein.
离子迁移谱(IMS)可作为快速、定性的筛查工具,用于分析掺假的减肥产品。我们之前已经表明,从膳食补充剂中提取到甲醇中的西布曲明可以使用便携式 IMS 光谱仪在低水平(2ng)下检测到,并且已经采用了类似的方法来分析其他减肥产品掺假物。一项 FDA 合作研究有助于确定氟西汀的检测限为 2ng。我们还评估了更易于获得、毒性更小的提取溶剂,发现异丙醇和水与甲醇相当。异丙醇比水更受青睐有两个原因:(1)水会增加分析时间;(2)水溶液更容易受到 pH 值变化的影响,这会影响西布曲明的检测。除了西布曲明和氟西汀,我们还调查了 11 种减肥掺假物;布美他尼、芬氟拉明、呋塞米、奥利司他、酚酞、苯丙胺、苯妥英、利莫那班、舍曲林和两种西布曲明类似物,去甲基西布曲明和二甲西布曲明,使用便携式和台式离子迁移谱仪。在这 13 种活性药物成分(APIs)中,便携式和台式离子迁移谱仪能够筛选出其中 10 种 API 的产品。所开发的程序已应用于两种减肥膳食补充剂,使用便携式和台式仪器。一种产品含有二甲西布曲明,另一种产品含有二甲西布曲明和酚酞。