Determination of Content of Antioxidant Sodium Sulfite in Etimicin Sulfate Injection with Ion Chromatography / 中国药学杂志

ABSTRACT

OBJECTIVE: To establish an ion chromatography method for measuring the content of sodium sulfite as an antioxidant in etimicin sulfate injection. METHODS: DionexIonPac AS11-HC (4 mm×250 mm) and DionexIonPac AG1-HC (4 mm×50 mm) were employed as anion analytical column and anion guard column to separate sodium sulfite and determine its content. Gradient elution was carried out with potassium hydroxide solution at the flow rate of 1.0 mL·min-1. Conductivity detector was used with the suppressor current set at 99 mA, the conductivity pool was maintained at 35℃ and the column temperature was maintained at 30℃. RESULTS: A good linear relationship was found between the peak response and the concentration range of 8-80 μg·mL-1. The detection limit was determined to be 0.02 μg·mL-1 (S/N=3), and the quantitation limit was 0.09 μg·mL-1 (S/N=10). CONCLUSION: In this paper, we set up an analytical technique with such characteristics as rapidity, accuracy and reproducibility, which will serve to control the dosage of sodium sulfite. So far, it seems appropriate to use sodium sulfite as an antioxidant, but its amount in pharmaceutical preparations should be further optimized and decreased in the future.