HPLC法测定注射用拉氧头孢钠有关物质___
HPLC determination of related substances in latamoxef sodium for injection
分类号：
出版年·卷·期（页码）：2009,29 (10):0-0
DOI:
10.16155/j.0254-1793.2017.01.01
-----摘要：-------------------------------------------------------------------------------------------
目的：建立用高效液相色谱方法测定注射用拉氧头孢钠的有关物质。方法：采用 Diomonsil C18柱（150 mm×4.6 mm，5 μm），以0.01 mol•L-1醋酸铵溶液-甲醇（19∶1）为流动相，流速为0.5 mL•min-1，以自身对照法测定，检测波长为254 nm。结果：线性范围为26.52～1065.8 ng，r＝0.9999，最低检测限为0.02 ng。结论：该方法准确、简便，可以用于注射用拉氧头孢钠的有关物质测定。
-----英文摘要：---------------------------------------------------------------------------------------
Objective:To determine the related substances in latamoxef sodium for injection by HPLC.Method:Column was Diomonsil C18（150 mm×4.6 mm，5 μm），the mobile phase was 0.01 mol•L-1ammonium acetate and methanol in the ratio of 19∶1.The detection wavelength was 254 nm and the flow rate was 0.5 mL•min-1.Results:Excellent linear relation in the range of 26.52-1065.8 ng（r＝0.9999）was observed in latamoxef.The limit of detection was 0.02 ng.Conclusion:The method is accurate and simple and it can be used for determination of the related substances in latamoxef sodium for injection.
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1 ChP（中国药典）.2005.Vol Ⅱ（二部），Appendix(附录)28 2State drug standard, New formal standard Vol32（国家药品标准,新药转正标准第32册）WS1-(X-006)-2003Z 104
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