摘要
目的:为控制匹伐他汀钙的质量,合成原药中3种有关物质。方法:以(8)为原料经不对称羟醛缩合、反立体选择性还原得到了有关物质(3)和有关物质(4)。匹伐他汀钙经DDQ氧化得到了有关物质(7)。结果与结论:合成了匹伐他汀钙原药中3种有关物质,并经~1H-NMR和MS等确证结构,纯度经HPLC检测均在96%以上,可以作为匹伐他汀钙原药质量控制的对照品。
Objective： To perform the quality control of were synthesized. Methods： The related substance （3） and pitavastatin calcium, （4） were synthesized three related substances by the asymmetric aldol condensation and anti-stereoselective reduction started from compound （8）. The pitavastatin calcium was oxidized by DDQ to yield the related substance （7）. Results and Conclusion： Three related substances were synthesized and their chemical structures were confirmed by 1H-NMR and MS. Their purities were over 96% by the detection of HPLC, and they can be used as the reference substances in the quality control of pitavastatin calcium.
出处
《药学与临床研究》
2017年第4期286-288,共3页
Pharmaceutical and Clinical Research
关键词
匹伐他汀钙
有关物质
合成
Pitavastatin calcium
Related substance
Synthesis
