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目的:建立伊班膦酸钠原料中伊班膦酸的离子色谱分析方法。方法:采用Ion Pac AS11阴离子交换色谱柱,利用在线淋洗液发生器自动产生氢氧化钾梯度淋洗液(20~40 mmol·L-1,时间程序为25 min),以自动再生抑制型电导检测。结果:该方法具有较高的精密度[重复性平均值为100.1%,RSD=0.6%(n=6);中间精密度平均值为103.0%,RSD=0.6%(n=6);进样精密度RSD=0.4%(n=5)]、准确度[3个浓度水平的平均回收率(n=3)分别为100.2%、100.5%、102.7%,RSD分别为0.4%、1.2%、1.7%]和专属性,伊班膦酸钠的线性范围为6.06~96.90μg·m L-1,r=0.9999。结论:经方法学验证,本方法可用于伊班膦酸钠中伊班膦酸含量的快速分析。
Objective: To establish an ion chromatography method for ibandronic acid in ibandronate sodium. Methods: Ion Pac AS11 anion exchange column was used to automatically generate potassium hydroxide gradient eluent (20 ~ 40 mmol·L-1, time program: 25 min) with on-line eluent generator. Detection. RESULTS: The method was highly accurate (average repeatability was 100.1%, RSD = 0.6% (n = 6); median precision was 103.0% with RSD = 0.6% (n = 6) The accuracy was 100.2%, 100.5% and 102.7%, respectively, and the RSDs were 0.4%, 1.2% and 1.7% respectively for the accuracy of RSD (0.4% for n = 5) %] And specificity, ibandronate linear range of 6.06 ~ 96.90μg · m L-1, r = 0.9999. CONCLUSIONS: This method is validated by methodological validation for the rapid analysis of ibandronic acid in ibandronate.