Determination of Calcium Disodium Edetate in Fosaprepitant Dimeglumine for Injection by HPLC / 中国药师

ABSTRACT

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.