离子色谱法同时测定盐酸左沙丁胺醇雾化吸入溶液中3种辅料含量

Simultaneous Determination of Three Excipients in Levosalbutamol Hydrochloride Atomized Inhalation Solution by Ion Chromatography

目的建立离子色谱法同时测定盐酸左沙丁胺醇雾化吸入溶液中依地酸二钠、硫酸、枸橼酸钠含量的方法。方法采用阴离子交换离子色谱法,色谱柱为Dionex IonPac^(TM)AS11-HC分析柱(4 mm×250 mm)和AS11-HC保护柱(4 mm×50 mm),淋洗液为30 mmol/L氢氧化钾溶液,流速为1.0 ml/min,抑制器为Dionex AERS 500(4 mm),抑制电流为75 mA,电导检测器,柱温为30℃,进样体积为25μl。结果依地酸根离子、硫酸根离子、枸橼酸根离子质量浓度分别在2.30~57.60,13.38~334.43,35.38~884.57μg/ml的范围内与峰面积线性关系良好,相关系数分别为0.9992,0.9999,0.9995;平均加样回收率分别为100.71%,100.91%,99.47%(n=9),RSD分别为1.56%,1.74%,1.73%(n=9);精密度、重复性、稳定性试验的RSD均小于2%(n=6)。结论建立的离子色谱法操作简便,重复性强,准确灵敏,3种被测组分峰型良好,分离度高,该方法可同时测定盐酸左沙丁胺醇雾化吸入溶液中依地酸二钠、枸橼酸钠、硫酸的含量。

Objective To establish a method for the simultaneous determination of disodium edetate,sulfuric acid and sodium citrate in Levosalbutamol Hydrochloride Atomized Inhalation Solution by ion chromatography.Methods The anion exchange ion chromatography method was adopted,which was performed on a Dionex IonPac^(TM) AS11-HC analytical column(4 mm×250 mm)and an AS11-HC protective column(4 mm×50 mm).The isocratic elution was performed,using 30 mmol/L potassium hydroxide solution at the rate of 1.0 ml/min as eluent.Dionex AERS 500(4 mm)suppressor was adopted with the suppression current of 75 mA,and the electrical conductivity detector was adopted.The column temperature was 30°C and the injection volume was 25μl.Results Edetate ion,sulfate ion and citrate ion had good linear relationships with the peak area in the range of 2.30-57.60μg/ml,13.38-334.43μg/ml and 35.38-884.57μg/ml,respectively,and the correlation coefficients were 0.9992,0.9999 and 0.9995,respectively.The average recoveries of edetate ion,sulfate ion and citrate ion were 100.71%,100.91%and 99.47%(n=9),and the RSDs were 1.56%,1.74%and1.73%(n=9).The RSDs of precision,repeatability and stability tests were all less than 2%(n=6).Conclusion This established ion chromatography can simultaneously determine the contents of disodium edetate,sodium citrate and sulfuric acid in Levosalbutamol Hydrochloride Atomized Inhalation Solution.