色谱柱分类数据库用于指导天然药物化学对照品色谱纯度测定时色谱柱理性选择（英文）
发布时间：2018-09-03 12:58
【摘要】：由于中药化学对照品多数来源于动植物药材,很容易混有结构类似物,故有机杂质测定是可能影响其化学对照品赋值准确性的关键风险因素。中药化学对照品的有机杂质测定通常采用药典收载或文献报道的高效液相色谱法,这些方法通常仅规定"以十八烷基硅烷键合硅胶为填充剂",无适宜色谱柱的品牌信息,或者实验室无文献所用的色谱柱品牌,而目前市场上已有800多种品牌的C18柱,生产工艺的不同导致不同品牌C18柱的选择性有差异,甚至差异显著。这很容易出现由于色谱柱选择不适宜而导致测定结果不准确的风险。该文采用国外色谱柱分类数据库指导对照品纯度考察时色谱柱的理性选择,尽可能减少色谱柱盲选可能导致的纯度结果不准确的风险。首先,用数据库挑选2根选择性差异显著的色谱柱(选择性因子F≥6)进行平行实验,以尽可能反映采用不同品牌色谱柱可能出现的分离效果差异。如果这2根色谱柱的分离效果及纯度测定结果无显著性差异,则可以交叉验证该对照品纯度测定的准确性。否则需要从数据库中选择另外1根与之前试验中分离效果更好、选择性相似的色谱柱进行纯度结果验证。在N-反式-p-对香豆酰基酪胺和表儿茶素没食子酸酯首批对照品的纯度考察中,使用了上述策略并验证了其有效性和科学性,计划推广应用至更多的中药化学对照品,特别当其可能含碱性或弱酸性化合物时,更应该尝试采用本文推荐的色谱柱选择策略交叉验证其纯度测定结果的准确性。
[Abstract]:Because most of the chemical reference materials of traditional Chinese medicine come from animal and plant herbs, it is easy to mix with structural analogs, so the determination of organic impurities is the key risk factor that may affect the accuracy of assignment of chemical reference materials. The determination of organic impurities in chemical reference substances of traditional Chinese medicine is usually determined by high performance liquid chromatography (HPLC) carried by pharmacopoeia or reported in the literature. These methods usually only stipulate that "octadecyl silane bonded silica gel is used as filler" and there is no brand information suitable for chromatographic columns. There are more than 800 brands of C18 columns in the market, and the different production process leads to the difference of the selectivity of C18 columns of different brands, or even significant difference. This is prone to the risk of inaccurate results due to inappropriate column selection. In this paper, the rational selection of chromatographic column is guided by foreign chromatographic column classification database in order to reduce the risk of inaccuracy of purity result caused by blind selection of chromatographic column as far as possible. Firstly, two chromatographic columns (F 鈮，
本文编号：2220043
[Abstract]:Because most of the chemical reference materials of traditional Chinese medicine come from animal and plant herbs, it is easy to mix with structural analogs, so the determination of organic impurities is the key risk factor that may affect the accuracy of assignment of chemical reference materials. The determination of organic impurities in chemical reference substances of traditional Chinese medicine is usually determined by high performance liquid chromatography (HPLC) carried by pharmacopoeia or reported in the literature. These methods usually only stipulate that "octadecyl silane bonded silica gel is used as filler" and there is no brand information suitable for chromatographic columns. There are more than 800 brands of C18 columns in the market, and the different production process leads to the difference of the selectivity of C18 columns of different brands, or even significant difference. This is prone to the risk of inaccurate results due to inappropriate column selection. In this paper, the rational selection of chromatographic column is guided by foreign chromatographic column classification database in order to reduce the risk of inaccuracy of purity result caused by blind selection of chromatographic column as far as possible. Firstly, two chromatographic columns (F 鈮，
本文编号：2220043
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