高效液相色谱法测定盐酸多巴酚丁胺注射液中依地酸二钠的含量

目的 建立盐酸多巴酚丁胺注射液中依地酸二钠的含量测定方法.方法 色谱柱为Hibar C18(250mm×4.6mm,5μm),流动相为0.3％四丁基氢氧化铵溶液(pH=4.0)-水-乙腈(18∶45∶37),检测波长为254nm,流速为1.0mL·min-1,进样量为20μL.样品经稀释后加醋酸铜溶液7mL,直接进样分析.结果 依地酸二钠浓度在6.960-116.1μg·mL-1线性关系良好(r=0.9999)；检出限为0.46 μg· mL-1;样品平均回收率(n=9)为101.3％.结论 本方法简便、准确、灵敏度高、重复性好,可用于盐酸多巴酚丁胺注射液中依地酸二钠的含量测定.

HPLC determination of disodium edetate in dobutamine hydrochloride injection

Objective To establish an HPLC method for the determination of disodium edetate in dobutamine hydrochloride injection.Methods The Hibar C18(250 mm×4.6 mm,5 μm)column was used.The mobile phase consisted of 0.3% tetrabutylammonium hydroxide solution-water-acetonitrile(18∶45∶37).The flow rate was 1.0 mL·min-1,and the detection wavelength was 254 nm.The injection volume was 20 μL.Results This method showed excellent regression(r=0.999 9) at 6.960-116.1 μg·mL-1.The detection limit was 0.46 μg·mL-1.The average recovery(n=9) was 101.3%.Conclusion The method is simple,accurate,sensible and reproducible,which can be used for the quality control of disodium edetate in dobutamine hydrochloride injection.