摘要
目的建立分离及测定青蒿琥酯及其制剂中有关物质含量的高效液相色谱法。方法采用Dikma Diamonsil C_18柱(250 mm×4.6 mm,5μm),以磷酸缓冲液(p H=3.0)-乙腈(56∶44)为流动相,流速为1.0 mL/min,外标法测定,检测波长为216 nm。结果青蒿琥酯与已知杂质A,B,I能完全分离,相对保留时间一致,并可通过简单加热破坏方法得到杂质I,用于定性检测。结论该方法准确、快速、专属性强,适用于青蒿琥酯及其制剂中有关物质的测定。
Objective To establish an HPLC method for content determination of related substances in artesunate and its preparations.Methods The Dikma Diamonsil C18 column（250 mm × 4.6 mm,5 μm） was adopted with external standard method,the mobile phase was composed of buffer（pH = 3.0）-acetonitrice（56 ∶ 44）,the flow rate was 1.0 mL/min,and the detection wavelength was 216 nm.Results Artesunate could be completely separated from the known impurities A,B,I,and the relative retention time was consistent,and the impurity I could be obtained by a simple heating failure method for qualitative detection.Conclusion The method is accurate,rapid and specific,which is suitable for the determination of related substances in artesunate and its preparations.
作者
赵画
曾令高
Zhao Hua;Zeng Linggao(Chongqing Institute for Food and Drug Control,Chongqing,China 401121;Shanghai Food and Drug Packaging Material Control Center,Shanghai,China 201203)
出处
《中国药业》
CAS
2018年第12期19-21,共3页
China Pharmaceuticals
基金
全球基金项目-国家药品标准提高课题[GF2012-42]
