有关物质是药品中除活性有效成分之外的有机杂质。由于这类杂质大多具有潜在的生理活性，有的甚至具有毒性，因此药物中有关物质的精确定量分析十分重要。现有的分析技术如LC-MS/MS因需要难以获取且价格昂贵的标准品而受到限制。HPLC-ICP-MS是一种新型的分离检测技术，具有灵敏度高、特异性强、分析响应与被测物的化学结构无关等优点，对含ICP-MS可检测元素（如金属和杂元素）的化合物可实现无需分析标准品的定量测定。本研究拟通过利用化学衍生化和HPLC-ICP-MS技术构建一种无需分析标准品的药物中有关物质的定量分析新策略。通过含ICP-MS可检测元素的药物有关物质，考察HPLC-ICP-MS对其直接分离与检测的适用性；对于不含ICP-MS可检测元素的药物有关物质，探索基于金属元素引入的化学衍生化联合HPLC-ICP-MS的定量分析的可行性。本研究将为药物有关物质的定量分析提供一种新的解决方案。

Drug related compounds are organic impurities present in medicines related to the active pharmaceutical ingredient. Since most of these impurities have potential physiological activity and some are even toxic, the accurate quantification of drug related compounds is of key importance. The current commonly used analytical techniques, such as LC-MS/MS, are sometimes limited since they require the availability of hardly accessible and expensive analytical standards for all drug related compounds. HPLC-ICP-MS is a novel hyphenated technique with the advantages of high sensitivity, selectivity, and structure-independent analytical response. Since analytical response of this technique is only related to the monitored element (such as metals and hetero-elements), the quantification does not require analytical standards for all drug related compounds. The goal of this project is to develop a new strategy for the quantification of drug related compounds based on the combination of chemical derivatization and HPLC-ICP-MS. For the drug related compounds containing an ICP-MS detectable element, an investigation of the applicability of HPLC-ICP-MS for direct separation and detection will be performed. For the drug related compounds do not contain any ICP-MS detectable elements, the feasibility of using chemical derivatization (based on the introduction of metal element) combined with HPLC-ICP-MS determination for their accurate quantification will be investigated. The final aim of this project is to provide a new option for the quantification of drug related compounds.