摘要
目的:探讨二维柱切换高效液相色谱法测定维生素D含量的仪器连接的新方式。方法:通过多次试验,对影响维生素D含量测定的仪器连接的关键因素(捕集柱,定量环,紫外检测器等)进行考察,分析比较不同仪器连接方式的优缺点。结果:探讨建立了《中国药典》2020年版四部通则0722维生素D测定法第四法中第一维检测器与六通阀连接的新位点,由六通阀1号位置前端移至2号位置后端。结论:本研究的二维柱切换高效液相色谱法的仪器连接方式,提高了检测方法的准确度,减少了误差,为药品质量提高提供了依据。
Objective:To explore the new instrument connection mode for vitamin D assay by switching column two-dimensional HPLC.Methods:The critical factors(such as crab column,quantitative loop,UV detector and so on)for vitamin D assay were investigated by multiple experiments,and the advantages and disadvantages of the various instrument connection modes were compared.Results:The new connection site for one dimensional detector and six-way valve in general chapter 0722 method IV,ChP 2020 Vol IV was established and the connection site is changed from No.1 front end to No.2 back end.Conclusion:The established instrument connection mode for column switching two-dimensional HPLC increases the accuracy of assay and reduce the error.That provides the basis for the quality control.
作者
王珵
施洁明
张立雯
董顺玲
WANG Cheng;SHI Jieming;ZHANG Liwen;DONG Shunling(Guangzhou Institute for Drug Control,Guangzhou 510160,China)
出处
《中国药品标准》
CAS
2021年第6期531-535,共5页
Drug Standards of China
