• 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>The Journal of automatic chemistry >Development and Validation of LC-MS/MS for Analyzing Potential Genotoxic Impurities in Pantoprazole Starting Materials
【24h】

Development and Validation of LC-MS/MS for Analyzing Potential Genotoxic Impurities in Pantoprazole Starting Materials

机译：LC-MS / MS的开发和验证用于分析泮托拉唑原料中的潜在遗传毒性杂质

获取原文
           
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

Pantoprazole sodium (PPZS) is a selective proton pump inhibitor used in the prevention and treatment of gastric acid-related diseases. Six potentially genotoxic impurities (PGIs) are involved in 5-difluoromethoxy-2-mercapto-1H-benzimidazole (DMBZ), which is the starting material of PPZS. To date, no suitable method has yet been developed for PGI separation and quantification at the threshold of toxicological concern levels. In this study, a sensitive and reliable liquid chromatography-tandem mass spectrometry method was developed and validated for the quantitative analysis of six PGIs in DMBZ according to the guidelines of the International Council for Harmonization (ICH). The calibration curves showed good linearity within the studied range, and the correlation coefficient of fitting exceeded 0.998 for each impurity. The sensitivity of the proposed method was in the range of 0.6–10.0?ng/mL. Good recoveries were observed in the range of 94.32%–107.43% with RSD values below 6.5%. Quantitative analysis of impurities in substance batches of DMBZ showed the high efficiency of the developed method at a low level. Hence, the proposed method is practical and useful in the detection and qualification of PGIs in DMBZ and may be applied to ensure the safe use of PPZS in clinical treatment.
机译：PantoPrazole钠（PPZS）是一种用于预防和治疗胃酸相关疾病的选择性质子泵抑制剂。六种潜在的遗传毒性杂质（PGI）参与5-二氟甲氧基-2-巯基-1H-苯并咪唑（DMBZ），其是PPZ的原料。迄今为止，在毒理界限水平的阈值下，尚未制定合适的方法，以便PGI分离和定量。在该研究中，开发了一种敏感且可靠的液相色谱 - 串联质谱法，并根据国际协调理事会（ICH）理事会的指导方针进行了六个博士的定量分析。校准曲线在研究范围内显示出良好的线性度，并且每个杂质的配件相关系数超过0.998。所提出的方法的敏感性在0.6-10.0≤ng/ ml的范围内。观察到良好的回收率在94.32％-107.43％的范围内，RSD值低于6.5％。 DMBZ物质批次中杂质的定量分析显示出低水平发达方法的高效率。因此，该方法是实用的，可用于DMBz中PGI的检测和鉴定，并且可以应用于确保PPZ在临床治疗中的安全使用。

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