药物中杂质对照品的标定项目与纯度测定方法研究进展

Progress in study on calibration and purity determination method of impurity reference substance in drugs

药物中的杂质是否能被全面准确地控制,直接关系到药品的质量可控与安全性。《中国药典》多采用主成分自身对照法规定有关物质的限度,而国外药典中多用到杂质对照品进行检测,这也就要求杂质对照品符合一定的质量标准后方可使用。对照品的标定中常涉及的项目包括纯度测定、结构确证、含量测定等,考虑到杂质对照品的微量性,标定时选择合适的分析方法十分重要,如进行纯度测定可使用高效液相色谱法、差示扫描量热法等试样用量少的分析仪器。

Whether the impurity in the drug can be fully comprehensive and accurately controlled,directly related to the quality of the drug safety and controllability.The principal component self-control method used in Chinese Pharmacopoeia to regulate material limit,and foreign methods used impurity reference,which requires the impurity reference substance to achieve a certain quality standard.Standard calibration usually includes purity determination,structure analysis,determination,and so on.Considering the impurity reference substance is traceful,so appropriate analysis method is very important.Less sample analysis instrument,such as high performance liquid chromatography,differential scanning calorimetry can be used for purity determination.