...
  • 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>Pharmaceutical Methods >A New Stability Indicating High Performance Liquid Chromatography Method for the Estimation of Ruxolitinib in Bulk and Tablet Dosage Form
【24h】

A New Stability Indicating High Performance Liquid Chromatography Method for the Estimation of Ruxolitinib in Bulk and Tablet Dosage Form

机译：高效液相色谱法测定鲁索替尼大剂量和片剂剂量的新方法

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

摘要

Background: The present research work described about the systemic development of High-Performance Liquid Chromatography (HPLC) method for the quantitative determination of ruxolitinib in bulk and tablet dosage form. The subsequent validation and degradation study was also performed. Methods: The chromatographic Separation was achieved with a HPLC (Waters-717 series) Symmetry ODS RP Csub18/sub, 250mm x 4.6mm.i.d., 5μm,column with an isocratic mobile phase containing a mixture of acetonitrile: methanol: 1% Ortho phosphoric acid in the volume ratio of 70:25:5. The flow rate of the mobile phase was 1 ml/min and detection wavelength at 258 nm. The developed method was validated according to the ICH guidelines with respect to linearity, accuracy, precision, specificity, detection limits and robustness. Results: The precision of the results, stated as the %RSD was below 1.0%. The accuracy of the method demonstrated at three levels in the range of 50%, 100% and 150% of the specification limit. The calibration curve was linear over a concentration range from 5 to 200μg/ml with a correlation coefficient of 0.9997. The recovery of ruxolitinib was found to be in the range of 98 to 101%, whereas the detection limits were found to be 0.09 and quantitation limit was 0.29 μg/ml. Forced degradation study reveals its higher degradation at thermal and peroxide conditions in compare to other degradation condition. Conclusion: The present method was validated according to the ICH guidelines and it is applied successfully for the determination of ruxolitinib in tablets.
机译：背景：本研究工作描述了用于定量测定散装和片剂剂型鲁索替尼的高效液相色谱（HPLC）方法的系统开发。随后进行了验证和降解研究。方法：采用HPLC（Waters-717系列）Symmetry ODS RP C 18 ，250mm x 4.6mm.id，5μm色谱柱进行分离，色谱柱为等度流动相，其中包含乙腈混合物：甲醇：1％的正磷酸，体积比为70：25：5。流动相的流速为1 ml / min，检测波长为258 nm。所开发的方法已根据ICH指南验证了线性，准确性，精密度，特异性，检测限和耐用性。结果：以％RSD表示的结果精度低于1.0％。该方法的精度在规格极限的50％，100％和150％的三个水平上得到了证明。校正曲线在5至200μg/ ml的浓度范围内呈线性，相关系数为0.9997。鲁索替尼的回收率在98％到101％之间，而检出限为0.09，定量限为0.29μg/ ml。强迫降解研究表明，与其他降解条件相比，其在热和过氧化物条件下的降解程度更高。结论：该方法已按照ICH指南进行了验证，已成功用于片剂中ruxolitinib的测定。

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