CAJ | 학술논문

目的：建立泊马度胺有关物质的HPLC测定方法。方法：采用Inertsil ODS-3V柱（250 mm×4.6 mm，5μm）对降解杂质和工艺杂质进行定量分析；以辛烷磺酸钠缓冲液-乙腈（90∶10，A）与乙腈-甲醇（50∶50，B）为流动相，梯度洗脱；检测波长为215 nm。结果：在选定的色谱条件下泊马度胺与各杂质分离良好，6个杂质平均回收率均在83.4%至100.8%之间。结论：本法选择性高、重现性好，可作为泊马度胺质量控制的方法。
목적：건립박마도알유관물질적HPLC측정방법。방법：채용Inertsil ODS-3V주（250 mm×4.6 mm，5μm）대강해잡질화공예잡질진행정량분석；이신완광산납완충액-을정（90∶10，A）여을정-갑순（50∶50，B）위류동상，제도세탈；검측파장위215 nm。결과：재선정적색보조건하박마도알여각잡질분리량호，6개잡질평균회수솔균재83.4%지100.8%지간。결론：본법선택성고、중현성호，가작위박마도알질량공제적방법。
Objective: To establish an HPLC method for the determination of pomalidomide and its related substances. Methods: The test for degradation and process impurities was based on an Inertsil ods-3v (250 mm×4.6 mm, 5μm) column; Mobile phase consisted of octane sulfonic acid sodium buffer solution - methanol acetonitrile for gradient elution; The detection wavelength was set at 215 nm. Results: Related substances were completely separated from the main constituent. The recoveries were from 83.4% to 100.8%. Conclusion:This highly selective and reproducible HPLC method offers an option in the quality control of pomalidomide.