离子色谱法测定盐酸阿扎司琼氯化钠注射液中亚硫酸氢钠的含量

Determination of Sodium Bisulfite in Azasetron Hydrochloride and Sodium Chlodide Injection by Ion Chromatography

关键词:  离子色谱  盐酸阿扎司琼  亚硫酸氢钠

Key words:  ion chromatography  azasetron hydrochloride  sodium bisulfite

摘要:

目的 建立一种离子色谱法准确快速测定盐酸阿扎司琼氯化钠注射液中抗氧化剂亚硫酸氢钠含量的方法。方法 采用AS-11阴离子分析柱(4.6 mm×250 mm，5 μm) 对样品进行分离，以20 mmol·L^-1氢氧化钾溶液为淋洗液，流速1.0 mL·min^-1，抑制型电导检测器检测。样品用0.4%甲醛溶液稀释后直接进样。结果 NaHSO₃线性范围为4.07~ 30.51 μg·mL^-1，r=0.999 7；Na₂SO₄线性范围为1.59~159.0 μg·mL^-1，r=0.999 8；NaHSO₃、Na₂SO₄样品平均回收率(n=9)分别为98.82%，98.24%。结论 本方法操作简便、灵敏、稳定、选择性高，可用于盐酸阿扎司琼氯化钠注射液中亚硫酸氢钠含量的检测。

Abstract:

OBJECTIE To establish an ion chromatography method for rapid and precise determination of the content of antioxidant sodium bisulfite in azasetron hydrochloride and sodium chlodide injection. METHODS The AS-11 anion analytical column(4.6 mm×250 mm, 5 μm) was adopted to separate the samples with the eluent of 20 mmol·L^-1 potassium hydroxide. The flow rate was 1.0 mL·min^-1, and the suppressed conductivity detector was adopted. Samples were diluted with 0.4% formaldehyde solution followed by direct injection. RESULTS This method exhibited excellent regression(r=0.9997) in the range of 4.07-30.51 μg·mL^-1 for NaHSO₃ and regression(r=0.999 8) in the range of 1.59-159.0 μg·mL^-1 for Na₂SO₄, the average recovery (n=9) was 98.82%, 98.24%, respectively for NaHSO₃ and Na₂SO₄. CONCLUSION The method is simple, accurate, stable and precise, and can be userd for the determination of sodium bisulfite in azasetron hydrochloride and sodium chlodide injection.