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首页> 美国卫生研究院文献>other >Single Laboratory Validation of a Method for Determination of Glucosamine in Raw Materials and Dietary Supplements Containing Glucosamine Sulfate and/or Glucosamine Hydrochloride by High-Performance Liquid Chromatography with FMOC-Su Derivatization
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Single Laboratory Validation of a Method for Determination of Glucosamine in Raw Materials and Dietary Supplements Containing Glucosamine Sulfate and/or Glucosamine Hydrochloride by High-Performance Liquid Chromatography with FMOC-Su Derivatization

机译：FMOC-Su衍生化高效液相色谱法测定含硫酸葡萄糖胺和/或盐酸葡萄糖胺的原料和膳食补充剂中葡萄糖胺的方法的单实验室验证

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摘要

Single laboratory validation of a method for determination of glucosamine in raw materials and dietary supplements containing glucosamine sulfate and/or glucosamine hydrochloride by with high-performance liquid Chromatography FMOC-Su derivatization. Tests with 2 blank matrixes containing SAMe, vitamin C, citric acid, chondroitin sulfates, methylsulfonylmethane, lemon juice concentrate, and other potential interferents showed the method to be selective and specific. Eight calibration curves prepared over 7 working days indicated excellent reproducibility with the linear range at least over 2.0–150 μg/mL, and determination coefficients >0.9999. Average spike recovery from the blank matrix (n = 8 over 2 days) was 93.5, 99.4, and 100.4% at respective spike levels of 15,100, and 150%, and from the sample matrix containing glucosamine (n = 3) was 99.9 and 102.8% at respective levels of 10 and 40%, with relative standard deviations <0.9%. The method was also applied to 12 various glucosamine finished products and raw materials. The stability tests confirmed that glucosamine–FMOC-Su derivative once formed is stable at room temperature for at least 5 days. Limit of quantitation was 1 μg/mL and limit of detection was 0.3 μg/mL. The method is ready to proceed for the collaborative study.
机译：高效液相色谱FMOC-Su衍生化法测定包含硫酸葡萄糖胺和/或盐酸葡萄糖胺的原料和膳食补充剂中葡萄糖胺的方法的单实验室验证。对包含SAMe，维生素C，柠檬酸，硫酸软骨素，甲基磺酰甲烷，柠檬汁浓缩物和其他潜在干扰物的2种空白基质进行的测试表明，该方法具有选择性和特异性。在7个工作日内制备的8条校准曲线显示出优异的重现性，线性范围至少在2.0–150μg/ mL以上，测定系数> 0.9999。在15,100和150％的相应加标水平下，空白基质（2天内n = 8）的平均加标回收率分别为93.5、99.4和100.4％，从含葡萄糖胺的样品基质（n = 3）中的平均加标回收率分别为99.9和102.8含量分别为10％和40％时的％，相对标准偏差<0.9％。该方法还适用于12种各种葡糖胺成品和原料。稳定性测试证实，一旦形成的氨基葡萄糖-FMOC-Su衍生物在室温下至少稳定5天。定量限为1μg/ mL，检出限为0.3μg/ mL。该方法已准备好进行合作研究。

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