摘要
目的：建立高效液相色谱法测定注射用福沙匹坦二甲葡胺中乙二胺四乙酸钙钠的含量。方法：采用Agilent Zorbax Eclipse XDB C18（250 mm×4.6 mm,5μm）色谱柱；以0.2%四丁基氢氧化铵溶液（用磷酸调节pH4.0）-乙腈（85∶15）为流动相,流速为1.0 ml·min-1,检测波长为254 nm,柱温为35℃,进样量为20μl。结果：乙二胺四乙酸钙钠在26.06~104.24μg· ml-1（r=0.9998）范围内呈现良好的线性关系；平均回收率为99.51%（RSD=0.25%,n=9）。结论：该方法简便、灵敏、准确、专属性强,重复性好,可作为注射用福沙匹坦二甲葡胺中乙二胺四乙酸钙钠含量测定的方法。
Objective：To establish an HPLC method for the determination of calcium disodium edetate in fosaprepitant dimeglu-mine for injection. Methods：The chromatographic column was Agilent Zorbax Eclipse XDB C18（250 mm ×4.6 mm,5μm）. The mo-bile phase consisted of 0. 2% tetrabutylammonium hydroxide（adjusting pH to 4. 0 with phosphoric acid）-acetonitrile（85∶15）. The flow rate was 1. 0 ml·min-1 . The detection wavelength was 254 nm. The chromatographic column temperature was 35℃. The injection volume was 20μl. Results：The calibration curve was linear within the range of 26. 06-104. 24μg·ml-1（r=0. 999 8） for calcium di-sodium edetate. The average recovery was 99. 51% （RSD=0. 25%, n=9）. Conclusion： The method is simple, rapid, accurate, specific and reproducible, and can be used in the determination of calcium disodium edetate in fosaprepitant dimeglumine for injection.
出处
《中国药师》
CAS
2015年第5期711-713,共3页
China Pharmacist
基金
国家"重大新药创制"科技重大专项(编号:2010ZX09401-302)
