摘要
本文对抗生素杂质的各检测方法的研究进展进行了综述。常用的杂质检测法有高效液相色谱法(HPLC)、气相色谱法(GC)及凝胶渗透色谱法(GPC);GPC主要用于高分子聚合物的检测,而GC法用于挥发性杂质的检测。此外,还有毛细管电泳法(CE)、气相色谱一质谱联用技术(GC-MS)、核磁共振(NMR)光谱法及高效阴离子交换色谱-积分脉冲安培检测分析法等。本文重点阐述HPLC法结合色谱二维光谱相关法在杂质定位识别方面的应用和CE法及LC-MS法在抗生素杂质分析方面的应用情况,最后对各方法在杂质检测领域的发展前景进行展望。
In this article, we reviewed the detection methods for impurity of antibiotics. The commonly used methods are HPLC, GC, and GPC. GPC is used to determine high molecular polymers, and GC to determine volatile impuriy. In addition, CE, GC-MS, NMR and high-performance anion-exchange chromatography with inte- grated pulsed amperometric detection are included. We emphasize the application of HPLC combined with spectros- copy correlation on identification of impurity peaks, and employment of CE and LC-MS in impurity detection. Fi- nally, the development prospects of each detection method used in impurity analysis were forecasted.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2012年第13期1498-1502,共5页
Chinese Journal of New Drugs
关键词
抗生素
杂质
检测技术
antibiotics
impurity
detection method
