摘要
根据匹多莫德有关物质极性大小及立体结构差异,建立了4种高效液相色谱条件分别测定匹多莫德口服液的9个有关物质及降解产物。结果,在相应色谱条件下,各有关物质和降解产物与匹多莫德、其他杂质及辅料分离完全,方法回收率为94.1%~102.6%,RSD为0.64%~2.11%。
Four determination conditions of HPLC were established based on the polarities and the stereo structures of nine specific related substances and degradation products of pidotimod oral solution. The results showed that the specific related substances and degradation products could be fully separated from pidotimod, other impurities and the excipients under the corresponding chromatographic conditions. The recoveries were 94.1%-102.6 %, with RSDs of 0.64%-2.11%.
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
2016年第12期1568-1573,共6页
Chinese Journal of Pharmaceuticals
