• 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>Asian Journal of Chemistry: An International Quarterly Research Journal of Chemistry >Method Development and Validation of Ion Chromatography Method for Determination of Free Sulfate in Fondaparinux Sodium Pre-Filled Syringe
【24h】

Method Development and Validation of Ion Chromatography Method for Determination of Free Sulfate in Fondaparinux Sodium Pre-Filled Syringe

机译：离子色谱法测定Fordaparinux钠预填充注射器测定离子色谱法的方法的开发及验证

获取原文
获取原文并翻译 | 示例
           
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

A simple ion chromatography method was developed for the quantitative determination of free sulfate in fondaparinux sodium pre-filled syringe for injection. Chromatographic separation was achieved on an anion-exchange resin column made of super macro porous polyvinyl benzyl ammonium polymer cross-linked with divinyl benzene (250 x 4.0 mm) with a mobile phase consisting of 60 mM carbonate buffer solution. Conductivity detector was employed with a flow rate of 0.7 mL min~(-1), injection volume of 100 μL and column temperature of 30 °C. Retention time of sulfate (SO4~(-2)) was eluted at about 10.4 min. The developed method was validated in according to ICH Q2(R1) guideline and was found to be specific, precise, accurate, linear and robust. The precision was evaluated with six individual spiked samples of sulfate on Fondaparinux sodium for injection. The proposed method is linear (r~2> 0.9991) and accurate, mean recoveries were 99.2-117.8 % at 3 different levels (50-150%). The robustness was performed by changing the flow rate of mobile phase (0.7 ± 0.lmL min~(-1)) and column temperature (30 ± 2 °C). The proposed method is capable to determine free sulphate in fondaparinux sodium for injection in presence of excipients used in pharmaceutical formulation and also in its active pharmaceutical ingredient.
机译：一个简单的离子色谱法是为在用于注射的磺达肝素的预填充注射器钠定量测定游离硫酸的开发。色谱分离在由阴离子交换树脂柱来实现超级宏多孔聚乙烯基苄铵聚合物与二乙烯基苯（250×4.0毫米），由60mM的碳酸缓冲液流动相的交联。导检测器是采用具有0.7毫升分钟〜（-1），100μL的注射体积和30℃柱温的流速。硫酸盐的保留时间（SO4〜（-2））在约10.4分钟被洗脱。所提出的方法在根据ICH Q2（R1）准则进行了验证，并发现，具体而言，精确，准确，线性和鲁棒性。精度的溶液用磺达肝素钠注射硫酸的六个单独的加标样品进行评价。所提出的方法是线性关系（r〜2> 0.9991）和准确的，平均回收率为在3倍不同的水平（50-150％）99.2-117.8％。的鲁棒性通过改变流动相的流动速率（0.7±0.lmL分钟〜（-1）），柱温（30±2℃）下进行。所提出的方法能够确定并还在其活性药物成分在磺达肝素钠注射用药物制剂所用的赋形剂的存在游离硫酸盐。

著录项

相似文献

  • 外文文献
  • 中文文献
  • 专利
获取原文

客服邮箱：kefu@zhangqiaokeyan.com

京公网安备：11010802029741号 ICP备案号：京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有

  • 客服微信

  • 服务号