HPLC法测定注射用艾司奥美拉唑钠中依地酸二钠的含量

Determination of disodium edentate in esomeprazole sodium for injection by HPLC

目的:建立注射用艾司奥美拉唑钠中依地酸二钠含量的测定方法。方法:色谱柱为Waters SunFire C_(18)(4.6 mm×150 mm, 5μm),流动相为乙腈-0.36%四丁基氢氧化铵溶液(用磷酸调节pH值至7.4)(30∶70),柱温为35℃,检测波长为254 nm,流速为1.0 mL·min^(-1),进样量为10μL。结果:依地酸二钠在6.14~61.35μg·mL^(-1)范围内线性关系良好(r=0.999 9),平均回收率为99.32%,RSD为0.96%(n=9),测得6批样品的依地酸二钠含量在1.43~1.57 mg·支^(-1)范围内。结论:本方法简单准确,重复性好,可用于注射用艾司奥美拉唑钠中依地酸二钠的含量测定。

Objective:To establish an HPLC method for determination of disodium edetate in esomeprazole sodium for injection.Methods:The test was performed in Waters SunFire C_(18) column(4.6 mm×150 mm,5μm)under isocratic elution of acetonitrile-0.36%tetrabutylammonium hydioxide solution(adjusting pH to 7.4 with phosphoric acid)(30∶70).The column temperature was 35℃,and the detection wavelength was 254 nm.The flow rate was 1.0 mL·min^(-1) and the injection volume was 10μL.Results:The calibration curve of disodium edetate was linearity of 6.14-61.35μg·mL^(-1)(r=0.9999).The average recovery was 99.32%with RSD as 0.96%(n=9).The contents of disodium edentate in 6 batches of samples were 1.43^(-1).57 mg per vial.Conclusion:The established method is simple and accurate and has the good repeatability.It is applicable to assay of disodium edetate in esomeprazole sodium for injection.