摘要
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。
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.
出处
《中国药品标准》
CAS
2014年第5期374-377,共4页
Drug Standards of China
