离子色谱法测定伊班膦酸钠注射液主成分的方法探讨
发布时间：2018-10-10 15:49
【摘要】：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。
[Abstract]:In order to establish an ion chromatographic method for the determination of ibandronic acid in ibandronate sodium injection, a Ion Pac AS18 anion exchange column was used. The gradient leaching solution of potassium hydroxide (1270 mmol L-1) was automatically generated by the on-line eluent generator. The time program was 17 min), and automatic regenerative inhibition conductance detection was used. The results showed that the linear correlation coefficient R _ 2 ~ (2 +) was 0.9995 in the range of 0 ~ 75.25 g mL ~ (-1) for ibandronic acid, and there was a significant linear correlation between the concentration of ibandronic acid and the concentration of ibandronic acid in the range of 0 ~ 75.25g mL ~ (-1). The peak area RSD is 0.21, the retention time RSD is 0.01, the number of theoretical plates is more than 50000, the applicability of the method system is good, the RSD value of Ibanphosphonic acid content in 5 samples is 0.80, less than 2.0, and the method has good repeatability. The recoveries of the three concentration levels of the tested samples were between 99 and 101%, and the RSD of the standard added recovery test was less than 1.00, which met the requirements of the drug regulations. The method is stable, reproducible and high recovery. It can be used to determine the content of principal components in ibandronate sodium injection.
【作者单位】： 安徽农业大学茶与食品科技学院;安徽农业大学生物技术中心;兆科药业(合肥)有限公司;
【基金】：安徽省自然科学基金面上项目(1608085MC54) 安徽省高校自然科学科学研究项目重点项目(KJ2015A060) 安徽农业大学青年科学基金重点项目(2014zr009),安徽农业大学引进与稳定人才基金项目(yj2015-19)共同资助
【分类号】：O657.75;R927.2
本文编号：2262359
[Abstract]:In order to establish an ion chromatographic method for the determination of ibandronic acid in ibandronate sodium injection, a Ion Pac AS18 anion exchange column was used. The gradient leaching solution of potassium hydroxide (1270 mmol L-1) was automatically generated by the on-line eluent generator. The time program was 17 min), and automatic regenerative inhibition conductance detection was used. The results showed that the linear correlation coefficient R _ 2 ~ (2 +) was 0.9995 in the range of 0 ~ 75.25 g mL ~ (-1) for ibandronic acid, and there was a significant linear correlation between the concentration of ibandronic acid and the concentration of ibandronic acid in the range of 0 ~ 75.25g mL ~ (-1). The peak area RSD is 0.21, the retention time RSD is 0.01, the number of theoretical plates is more than 50000, the applicability of the method system is good, the RSD value of Ibanphosphonic acid content in 5 samples is 0.80, less than 2.0, and the method has good repeatability. The recoveries of the three concentration levels of the tested samples were between 99 and 101%, and the RSD of the standard added recovery test was less than 1.00, which met the requirements of the drug regulations. The method is stable, reproducible and high recovery. It can be used to determine the content of principal components in ibandronate sodium injection.
【作者单位】： 安徽农业大学茶与食品科技学院;安徽农业大学生物技术中心;兆科药业(合肥)有限公司;
【基金】：安徽省自然科学基金面上项目(1608085MC54) 安徽省高校自然科学科学研究项目重点项目(KJ2015A060) 安徽农业大学青年科学基金重点项目(2014zr009),安徽农业大学引进与稳定人才基金项目(yj2015-19)共同资助
【分类号】：O657.75;R927.2
【相似文献】
相关期刊论文 前3条
1 安静;张俊贞;卢彦芳;倪美萍;蒋晔;;伊班膦酸钠注射液的流动注射化学发光法测定[J];中国医药工业杂志;2012年02期
2 谢赞;蒋晔;;离子对反相高效液相色谱法分离伊班膦酸钠及其有关物质[J];分析试验室;2006年03期
3 郭跃龙;韩继永;端亮;王押林;;钼蓝比色法测定伊班膦酸钠注射液中的游离磷酸盐[J];华西药学杂志;2014年04期
，本文编号：2262359
本文链接：https://www.wllwen.com/yixuelunwen/yiyaoxuelunwen/2262359.html
最近更新
教材专著
