离子色谱法测定妥布霉素地塞米松滴眼液中依地酸二钠含量

Content Determination of Disodium Edetate in Tobramycin and Dexamethasone Eye Drop by Ion Chromatography

目的建立测定妥布霉素地塞米松滴眼液中依地酸二钠含量的离子色谱法。方法色谱柱为Dionex IonPac^(TM)AS11-HC分析柱(250 mm×4 mm),Dionex IonPac^(TM)AG11-HC保护柱(50 mm×4 mm),淋洗液为30 mmol/L氢氧化钾溶液,流速为1.0 m L/min,检测池温度为25℃,进样量为25μL,AERS 500(4 mm)抑制器,抑制器电流为75 m A,以电导检测器检测。结果依地酸二钠的质量浓度在5.58~111.66 mg/L范围内与峰面积线性关系良好(r=0.9999,n=6),定量限为23.25 ng;精密度、稳定性、重复性试验的RSD均小于2.0%(n=6);平均加样回收率为99.52%,RSD为0.91%(n=9)。结论该方法操作简便,准确度高,稳定性好,可用于测定妥布霉素地塞米松滴眼液中依地酸二钠的含量。

Objective To establish an ion chromatography(IC)method for the content determination of disodium edetate in Tobramycin and Dexamethasone Eye Drop.Methods The chromatographic column was Dionex IonPac^(TM)AS11-HC analytical column(250 mm×4 mm),Dionex IonPac^(TM) AS11-HC protective column(50 mm×4 mm),the isocratic elution was 30 mmol/L potassium hydroxide solution,the flow rate was 1.0 m L/min,the temperature of the detection cell was 25℃,and the injection volume was 25μL.AERS500(4 mm)suppressor was adopted with a current of 75 m A.The conductivity detector was adopted.Results The linear range of disodium edetate was 5.58-111.66 mg/L(r=0.9999,n=6),and the limit of quantification(LOQ)was 23.25 ng.The RSDs of precision,stability and repeatability tests were less than 2.0%(n=6).The average recovery of disodium edetate was 99.52%with an RSD of 0.91%(n=9).Conclusion The method is simple,accurate and stable,which can be used for the content determination of disodium edetate in Tobramycin and Dexamethasone Eye Drop.