Simultaneous Determination of Three Excipients in Levosalbutamol Hydrochloride Atomized Inhalation Solution by Ion Chromatography
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 IonPacTM 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 ℃ and the injection volume was 25 μl.Results Edetate ion,sulfate ion and citrate ion had good linear relationships with the peak area in the range of 2.30-57.60 μg/ml,13.38-334.43 μg/ml and 35.38-884.57 μg/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.
ion chromatographyLevosalbutamol Hydrochloride Atomized Inhalation Solutiondisodium edetatesulfuric acidsodium citrate