富马酸喹硫平杂质对照品的研制

Development of impurity reference substance for quetiapine fumarate

目的:对富马酸喹硫平杂质B、杂质G、杂质H、杂质I等的对照品进行标定研制,用于该品种相关国家标准中有关物质检查。方法:采用LC-MS法及核磁共振波谱(NMR)法等对杂质B、杂质G、杂质H、杂质I进行结构确证。采用HPLC法进行纯度分析,采用质量平衡法计算各个杂质的含量,并用核磁共振定量法辅助定值。结果:杂质B、杂质G、杂质H、杂质I的含量分别为98.00%,99.28%,98.94%和97.84%。结论:建立了首批富马酸喹硫平杂质B、杂质G、杂质H、杂质I的标准物质,满足了国内富马酸喹硫平及制剂的质量控制需要。

Objective:The impurity reference substances B,G,H,and I were calibrated and developed,which can be used for the inspection of relevant national standards and related substances of this variety.Methods:The structures of impurities B,G,H and I were identified by LC-MS and NMR.HPLC method was used for purity analysis,mass balance method was used to calculate the content of various impurities,and quantitative nuclear magnetic resonance was used to assist in calibration.Results:The contents of impurities B,G,H and I are 98.00%,99.28%,98.94%and 97.84%,respectively.Conclusion:The first batch of national standard substances of impurities B,G,H and I of quetiapine fumarate was successfully developed,satisfying the quality control needs of quetiapine fumarate and its formulations in China.