HPLC法测定丙泊酚注射液中乙二胺四乙酸二钠含量

HPLC determination of EDAT-Na_2 in Propofol Injection

目的:建立丙泊酚注射液中乙二胺四乙酸二钠含量的HPLC检测方法。方法:采用Phenomenex Luna C18柱(100 mm×4.6 mm,5μm),梯度洗脱流动相A为0.66%四丁基氢氧化铵溶液-乙腈(3∶1)(用磷酸调pH至6.5),B为水-甲醇(1∶9),流速1.0 mL·min-1,检测波长为260 nm。结果:乙二胺四乙酸二钠峰不受辅料干扰,在20～80μg·mL-1浓度范围内线性关系良好(r=0.9999),高、中、低3种不同浓度的回收率分别为100.7%,100.5%,100.7%。结论:本方法操作简便,精密度好,结果准确可靠,可用于该制剂的质量控制。

Objective：To establish an HPLC method for determination of EDAT-Na2 in propofol injection.Methods：Phenomenex Luna C18 column（100 mm×4.6 mm,5 μm）and gradient elution were used.Mobile phase A was 0.66% tetrabutylammonium hydroxide solution-acetonitrile（3∶1）（pH was adjusted to 7.0 by phosphoric acid）,and mobile phase B is water-methanol（1∶9）,the flow rate was 1.0 mL·min-1 and the detection wavelength was 260 nm.Results：The date showed that EDAT-Na2 in propofol injection could be detected excluding excipients interfering.Calibration curve was linear range of 20-80 μg·mL-1（r=0.9999）,and the average recoveries of its high,middle and low concentrations were 100.7%,100.5% and 100.7%,respectively.Conclusions：This method is simple,accurate and reliable,so it can be used for quality control of EDAT-Na2.