摘要
建立了高效液相色谱法检测肝素钠中核苷酸杂质含量的方法并进行了方法学研究。结果表明，适当的酶解时间约为6h；酶解溶液在5℃下16h内稳定；本检测方法重复性检查的RSD为4．38％；9种核苷酸在0．025～12．5μg／mL范围内线性良好，R∈（0．9997，0．9998）；3个水平的腺苷加样回收率均在90％以上，RSD为1．37％。该方法具有较好的可信度，可操作性强，可用于肝素中核苷酸含量的测定。
A method for detection of nucleotidic impurities in heparin is established by HPLC. The methodological research shows that about 6 hours are required for enzyme digest. The solution digested by enzyme is stable within 16 hours at 5℃. An excellent reproducibility is achieved with a RSD of 4. 38%. 9 nucleotides show good linearity with correlation coefficient （R） of 0. 999 7 -0. 999 8 over the mass concentration range of 0.025 - 12. 5 μg/mL. The recoveries of adenosine at three different levels are all over 90% with a RSD of 1. 37%. Therefore, it can be used as a reliable assay method.
出处
《现代化工》
CAS
CSCD
北大核心
2015年第12期170-173,共4页
Modern Chemical Industry
关键词
肝素
核苷酸含量
高效液相色谱
方法学
heparin
nucleotidic impurities
HPLC
methodological research
