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Authenticity assessment of anabolic androgenic steroids in counterfeit drugs by 1H NMR†
Analytical Methods ( IF 2.7 ) Pub Date : 2018-02-12 00:00:00 , DOI: 10.1039/c8ay00158h Marcos Vinícius de M. Ribeiro 1, 2, 3, 4 , Nivaldo Boralle 1, 2, 3, 4 , Helena R. Pezza 1, 2, 3, 4 , Leonardo Pezza 1, 2, 3, 4
Analytical Methods ( IF 2.7 ) Pub Date : 2018-02-12 00:00:00 , DOI: 10.1039/c8ay00158h Marcos Vinícius de M. Ribeiro 1, 2, 3, 4 , Nivaldo Boralle 1, 2, 3, 4 , Helena R. Pezza 1, 2, 3, 4 , Leonardo Pezza 1, 2, 3, 4
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Anabolic steroids are synthetic hormone derivatives of testosterone, a masculine sex hormone. Their main effects include greater muscle size, physical strength, and resistance. The need for safe and reliable quality control of products and/or raw materials in the pharmaceutical industry makes analyses of active ingredients and other constituents of drug formulations extremely important for the manufacturers as well as users of these products. In this work, we propose the use of 1H NMR spectroscopy to analyze formulations containing anabolic steroids. Six types of anabolic steroids were studied (testosterone propionate, methyltestosterone, acetate methenolone, oxandrolone, nandrolone decanoate, and stanozolol), with analysis of 16 samples of anabolic drugs that are used in injectable, tablet, and capsule forms. The 1H NMR spectroscopic measurements were performed using a 600 MHz spectrometer, with deuterated chloroform (CDCl3) containing 0.03% TMS as the solvent. Of the 16 samples analyzed, four did not show the presence of the active principle stated on the label. For quantitative analysis, dimethyl sulfone (DMSO2) was used as an internal reference standard. All the analytical curves were obtained for concentration ranges of 1.0–16.0 mg mL−1. The limits of detection and quantification varied in the ranges 0.18–0.61 and 1.30–2.19 mg mL−1, respectively. The intra-day and inter-day precision RSD values were in the ranges 1.86–4.22% and 2.17–4.75%, respectively. The recovery values ranged from 95.2 to 104.0%. The spectroscopic results statistically agreed with those obtained by reference methods (HPLC).
中文翻译：
通过1 H NMR评估假药中合成代谢雄激素类固醇的真实性†
合成代谢类固醇是男性性激素睾丸激素的合成激素衍生物。它们的主要作用包括更大的肌肉大小，体力和抵抗力。制药行业对产品和/或原料的安全可靠质量控制的需求，使得对药物制剂的活性成分和其他成分的分析对于这些产品的制造商和用户而言极为重要。在这项工作中，我们建议使用11 H NMR光谱分析含有合成代谢类固醇的制剂。研究了六种类型的合成代谢类固醇（丙酸睾丸激素，甲基睾丸酮，乙酸美替龙，氧杂雄酮，癸酸诺龙和stanozolol），并分析了16种以注射剂，片剂和胶囊剂形式生产的合成代谢药物样品。的1个1 H NMR光谱测量使用600 MHz光谱进行的，用氘代氯仿（CDCL 3含0.03％TMS作为溶剂）。在分析的16个样品中，有4个未显示标签上注明的有效成分。为了进行定量分析，使用二甲基砜（DMSO 2）用作内部参考标准。获得了1.0–16.0 mg mL -1浓度范围内的所有分析曲线。检出限和定量限分别在0.18–0.61和1.30–2.19 mg mL -1之间变化。日内和日间精度RSD值分别在1.86–4.22％和2.17–4.75％的范围内。回收率范围为95.2至104.0％。光谱结果在统计学上与通过参考方法（HPLC）获得的结果一致。
更新日期：2018-02-12
中文翻译：
通过1 H NMR评估假药中合成代谢雄激素类固醇的真实性†
合成代谢类固醇是男性性激素睾丸激素的合成激素衍生物。它们的主要作用包括更大的肌肉大小，体力和抵抗力。制药行业对产品和/或原料的安全可靠质量控制的需求，使得对药物制剂的活性成分和其他成分的分析对于这些产品的制造商和用户而言极为重要。在这项工作中，我们建议使用11 H NMR光谱分析含有合成代谢类固醇的制剂。研究了六种类型的合成代谢类固醇（丙酸睾丸激素，甲基睾丸酮，乙酸美替龙，氧杂雄酮，癸酸诺龙和stanozolol），并分析了16种以注射剂，片剂和胶囊剂形式生产的合成代谢药物样品。的1个1 H NMR光谱测量使用600 MHz光谱进行的，用氘代氯仿（CDCL 3含0.03％TMS作为溶剂）。在分析的16个样品中，有4个未显示标签上注明的有效成分。为了进行定量分析，使用二甲基砜（DMSO 2）用作内部参考标准。获得了1.0–16.0 mg mL -1浓度范围内的所有分析曲线。检出限和定量限分别在0.18–0.61和1.30–2.19 mg mL -1之间变化。日内和日间精度RSD值分别在1.86–4.22％和2.17–4.75％的范围内。回收率范围为95.2至104.0％。光谱结果在统计学上与通过参考方法（HPLC）获得的结果一致。
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