离子色谱-抑制电导检测法同时测定唑尼沙胺原料中有关杂质

Simultaneous Determination of Four Impurities in Zonisamide by Ion Chromatography with Suppressed Conductivity Detector

目的建立一种快速、灵敏的离子色谱法,以同时测定抗癫痫药唑尼沙胺(zonisamide,ZNS)原料药中有关杂质1,2-苯并异唑-3-甲基磺酸钠(BOS-Na)和1,2-苯并异唑-3-乙酸(BOA-H)以及两种一般杂质Cl-和SO42-。方法采用离子交换色谱法,DionexIonpac AS4A-SC型阴离子分析柱,淋洗液为0.3mmol/L Na2CO3和1.6mmol/L NaHCO3的混合溶液,电导检测。结果各待测组分在所设计的质量浓度范围内线性关系良好(r=0.9975～0.9995),加样回收率为97.4%～103.4%。结论所建立的分析方法快速、准确、选择性好,可同时测定ZNS中有关杂质BOS-Na和BOA-H以及一般杂质Cl-和SO42-。

Objective To establish a rapid and sensitive ion chromatographic method for the simultaneous determination of four impurities in zonisamide （ZNS）： two main relative impurities sodium 1, 2 - benzisoxazole - 3 - methane sulfonate （BOS - Na） and 1, 2 - benzisoxazole - 3 - acetic acid （BOA- H）, two common impurities Cl- and SO4^2-. Methods The Dionex Ionpac AS4A-SC anion analytical column and suppressed conductivity detector were adopted in the method. The mixed solution containing 0. 3 mmol/L Na2CO3 and 1.6 mmol/L NaHCO3 was used as the eluent. Results For different added concentrations, each impurity showed good linear calibration （r = 0. 997 5- 0. 999 5） and good recoveries （97.4% -103.4% ）. Conclusion The established method is convenient, accurate and sensitive for the determination of impurities in ZNS products.