Determination of Residue Sulfate Ions in Cleaning Validation by Ion Chromatography
To verify if the residue of magnesium sulfate,sodium sulfate and potassium sulfate concentrate oral solution on the cleaning surface was below the safe limit,an ion chromatography method was established for the determination of residue sulfate ions.The chromatographic column was Dionex IonPacTM AS11-HC column,the guard column was Dionex IonPacTM AG11-HC;the eluent was 20 mmol/L potassium hydroxide solution;the flow rate was 1.0 mL/min;the injection volume was 10 μL and suppressor conductivity detector was ADRS 600(4 mm),and current value was 50 mA.There was good linear relationship between sulfate ions at 0.03-149.18 μg/ml(r=1.00,n=7).The limit of quantification(LOQ)was 0.030 μg/mnl,and the limit of detection(LOD)was 0.007 2 μg/mL.The recovery rate of each material was greater than 70％,and the SRSD value was lower than 20％.The established method is convenient,accurate,highly sensitive and specific,which can be used for rapid quantitative analysis of sulfate ions residues in the cleaning validation of production equipment.
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