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抗肿瘤活性化合物SM-1的有关物质检查方法研究
抗肿瘤活性化合物SM-1的有关物质检查方法研究
刘 珍1,梁 丰2,康志娇2,丁劲松1

1 中南大学药学院,长沙 410013;2 长沙晶易医药科技有限公司,长沙 410205
Examination method of related substances of anti-tumor compound SM-1
(1 School of Pharmaceutical Sciences, Central South University, Changsha 410013,China;2 Changsha King-eagle Medicine Science & Technology Co.,Ltd., Changsha 410205,China)

摘要参考文献相关文章

起始页:279

摘要:目的:建立高效液相色谱法检查SM-1的有关物质,为SM-1质量控制提供参考。方法:采用ZORBAX Eclipse XDB-C18柱(250 mm×4.6 mm,5 μm)为色谱柱,以0.01 mol·L-1 磷酸盐缓冲液[(取0.01 mol磷酸氢二钾,加水溶解并稀释至1 000 mL,用磷酸调节pH至(7.0±0.02)]为流动相A,以乙腈为流动相B,梯度洗脱,检测波长210 nm(L2、杂质B及自身对照中的SM-1)和325 nm(SM-1、ABT-D、杂质A及未知杂质)。结果:在上述色谱条件下,SM-1与各副产物及降解产物均能有效分离,杂质L2、ABT-D、杂质A及杂质B的检测限分别为33,15,40,33 ng·mL-1。结论:该方法专属性强、准确、灵敏,可用于SM-1原料药有关物质的检测分析及质量控制。

关键词:SM-1;有关物质;L2;ABT-D;高效液相色谱

通讯作者:丁劲松,男,教授,博士生导师,主要从事药物新制剂及新剂型研究工作。

基金项目:国家“重大新药创制”科技重大专项资助项目(2012ZX09103101-051)

作者简介:刘珍,女,硕士研究生,主要从事药物传递系统与新型给药系统研究。

Abstract:Objective:To establish an HPLC method for the examination of related substances of SM-1,in order to provide information for the quality control of SM-1. Methods:A ZORBAX Eclipse XDB-C18 column(250 mm×4.6 mm,5 μm) was used. The mobile phase consisted of solvent A (0.01 mol·L-1 potassium hydrogen phosphate soulution, pH adjusted to 7.0±0.02 by phosphate) and solvent B (acetonitrile). Gradient elution was adopted. The detection wavelengths were set at 210 nm for related substances L2,B and SM-1 for self-control and 325 nm for SM-1,related substances ABT-D,A and unknown related substances, respectively. Results:SM-1 could be separated well with its side products and degradation products. The limits of detection for the related substances L2,ABT-D,A and B were 33,15,40 and 33 ng·mL-1, respectively. Conclusion:The method is specific,accurate, and sensitive;it can be used for the determination of the related substances of SM-1.

Key words:SM-1;related substances;L2;ABT-D;HPLC

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