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为建立一种药物伊班膦酸钠注射液主成分-伊班膦酸的离子色谱分析方法,采用Ion Pac AS18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(12~70 mmol·L~(-1),时间程序为17 min),并使用自动再生抑制型电导检测。结果表明,伊班膦酸浓度在0~75.25?g·m L~(-1)范围内,线性相关系数R2=0.9995,呈现显著的线性相关关系;供试液重复进样5次,峰面积RSD为0.21%,保留时间RSD为0.01%,理论板数均大于50 000,方法系统适用性良好;5份供试样品溶液伊班膦酸含量的RSD值为0.80%,小于等于2.0%,方法重复性良好;供试样品3个浓度水平的回收率均在99%~101%之间,加标回收率试验的RSD均小于1.00%,符合药品规定要求。该方法稳定、重复性好且回收率高,可满足伊班膦酸钠注射液中主成分含量的测定要求。
To establish a method for the ion chromatography of ibandronic acid, the principal component of the ibandronate sodium injection, Ion Pac AS18 anion exchange chromatography was used to automatically generate a gradient of potassium hydroxide eluent using an online eluent generator (12-70 mmol·L -1, time program was 17 min), and the use of automatic regenerative inhibitory conductivity detection. The results showed that the ibandronic acid concentration was in the range of 0-75.25? G · m L -1 with a linear correlation coefficient of R2 = 0.9995, showing a significant linear correlation. The test solution was repeatedly injected for 5 times and the peak area RSD was 0.21%, retention time RSD was 0.01%, the number of theoretical plates was more than 50,000, and the system applicability was good. The RSD values of ibandronic acid in the five samples were 0.80% and 2.0% The repeatability was good. The recoveries of three concentrations of the tested samples were between 99% and 101%. The RSDs of the spiked recoveries were less than 1.00%, which met the requirements of the drug regulations. The method is stable, good repeatability and high recovery rate, which can meet the determination requirements of the main components in ibandronate sodium injection.