HPLC法测定盐酸氮卓斯汀滴眼液中依地酸二钠的含量

Determination of Disodium Edentate Content in Azelastine Hydrochloride Eye Drops by HPLC

目的:建立高效液相色谱测定盐酸氮卓斯汀滴眼液中依地酸二钠含量的方法。方法:色谱柱为Waters XBridge C18(150 mm×4.6 mm,5μm),梯度洗脱,流动相A为0.2%四丁基氢氧化铵溶液(用磷酸调节pH值至3.0)-乙腈(70︰30),流动相B为乙腈,柱温35℃,检测波长254nm,流速1.0 mL·min^(-1),进样量10μL。结果:依地酸二钠在10.29~102.92μg·mL^(-1)范围内线性关系良好(r=0.9992),平均回收率为98.17%,RSD为1.76%(n=9);测得3批样品依地酸二钠含量均符合规定。结论:本方法操作简单,准确,灵敏度高,可用于盐酸氮卓斯汀滴眼液中依地酸二钠的含量测定。

Objective:To establish a HPLC method for determination of disodium edetate content in azelastine hydrochloride eye drops.Methods:Waters XBridge C18(150 mm×4.6 mm,5μm)was used with gradient elution.Mobile phase A was 0.2% tetrabutylammonium hydioxide solution(pH 3.0 adjusted by phosphoric acid)-acetonitrile(70︰30)and mobile phase B was acetonitrile.The column temperature was 35℃.The detection wavelength was 254 nm.The flow rate was 1.0 mL·min^(-1) and the amount of injection was 10μL.Results:The calibration curve of disodium edetate was linear in the range of 10.29~102.92μg·mL^(-1)(r=0.9992),the average recovery was 98.17%,with RSD of 1.76%(n=9).The disodium edentate contents of 3 samples were all up to standard.Conclusion:The method is simple,accurate and sensitive,which can be used for the determination of disodium edetate in azelastine hydrochloride eye drops.