Capillary electrophoresis determination of diatrizoic acid and its impurities in diatrizoate radiopaque solutions
Capillary electrophoresis determination of diatrizoic acid and its impurities in diatrizoate radiopaque solutions
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DOI：
10.1007/bf01242676
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发表时间：
1997-01-01
期刊：
影响因子：
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通讯作者：
Wells, CE
中科院分区：
文献类型：
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作者：
Farag, SA;Wells, CE
建立了一种毛细管电泳方法，用于分离和测定不透射线注射溶液 (RSI) 中的泛影酸 (DTZA) 及其四种单碘和二碘降解产物（2-碘、4-碘、2,4-二碘和 2,6-二碘-3,5-二乙酰氨基苯甲酸）。 DTZA 及其降解物在适当的稀释度下进行测定，无需预处理。最佳条件包括使用低压进样（6 s）、样品和标准溶液的摩尔浓度小于分离缓冲液的摩尔浓度，以及调节缓冲液的摩尔浓度以在恒定的15 kV分离电压下获得50 μA的电流。每运行六次或更少后，将入口和出口缓冲液更换为来自同一批次的更多缓冲液。当将该方法应用于样品时，发现单碘和二碘杂质的 SI 水平均为 5-10 mg/ml。最佳方法的精度（峰面积测量）在 1.7-7.2% RSD 范围内，具体取决于浓度。在 5-60 mg/mL 的 DTZA 浓度范围内获得的线性相关系数为 0.997。
A capillary electrophoresis method has been developed for the separation and determination of diatrizoic acid (DTZA) and its four mono- and diiodo degradation products (2-iodo,4-iodo, 2,4-diiodo, and 2,6-diiodo-3,5-diacetamidobenzoic acid) in radiopaque solution for injection (RSI). DTZA and its degradants were assayed in suitable dilutions without pretreatment. Optimum conditions included the use of low-pressure sample injection (6 s), sample and standard solutions with a molarity less than that of the separation buffer, and adjustment of the buffer molarity to obtain a current of 50 mu A at a constant 15 kV separation voltage. After each six runs or less, the inlet and outlet buffer were replaced with more buffer from the same batch. When the method was applied to a sample of SI levels of 5-10 mg/ml were found for each of the mono and diiodo impurities. The optimum method showed a precision (peak area measurement) in the range 1.7-7.2% RSD, depending on the concentration. A linear correlation coefficient of 0.997 was obtained over a DTZA concentration range of 5-60 mg/mL.