药用辅料富马酸中杂质马来酸检测方法的研究

目的：建立检测药用辅料富马酸中杂质马来酸的HPLC方法。方法：采用Waters SunFire C18（4.6mm ×250mm，5μm）色谱柱，以水（用10％磷酸溶液调节pH值至3.0）-乙腈（85∶15）为流动相，流量1.0 mL·min^-1，检测波长为210nm，进样量10μL。结果：马来酸峰面积与浓度在0.1～10μg· mL^-1范围内线性关系良好（R^2＝0.9999），最低检测限和定量限分别为1ng和4ng。结论：该方法可用于富马酸中马来酸杂质的检测。

Study on Determination of Impurity Maleic Acid in Pharmaceutic Excipients Fumaric Acid

Objective：To establish an HPLC method for determination impurity maleic acid in pharmaceutic excipients fumaric acid.Methods： The chromatographic separation was performed on a Waters SunFire C 18 column （ 4.6mm×250mm, 5μm）.The mobile phase was consisted of water （ pH was adjusted to 3.0 by 10% phosphoric acid aqueous solution）：acetoni-trile （ 85∶15 ） at the flow rate of 1.0 mL· min^-1.The UV detection wavelength was set at 210 nm.Results： The linearity relationship of the peak area and concentration of maleic acid in the range of 0.1 -10μg· mL^ -1 was good.The LOD and LOQ of maleic acid were 1 ng and 4 ng, respectively.Conclusion： This method could be used for determination of maleic acid in fumaric acid.