Development and validation of a UPLC-MS method for determination of atazanavir sulfate by the “analytical quality by design” approach
作者: Chandni SahaN. Vishal GuptaR. S. Chandan
作者单位: 1Department of Pharmaceutics , JSS College of Pharmacy, JSS Academy of Higher Education & Research , Mysuru , Karnataka 570015 India
2 Department of Pharmaceutical Chemistry , JSS College of Pharmacy, JSS Academy of Higher Education & Research , Mysuru , Karnataka 570015 India
刊名: Acta Pharmaceutica, 2020, Vol.70 (1), pp.17-33
来源数据库: De Gruyter Journal
DOI: 10.2478/acph-2020-0008
关键词: Atazanavir sulfateUPLC-MS“analytical quality by design”
原始语种摘要: Abstract A UPLC-MS method for the estimation of atazanavir sulfate was developed using the “analytical quality by design” approach. The critical chromatographic quality attributes identified were retention time, theoretical plates and peak tailing. The critical method parameters established were percent of organic modifier, flow rate and injection volume. Optimization performed using Box-Behnken Design (BBD) established 10 % organic modifier, 0.4 mL min−1 flow rate and 6-µL injection volume as the optimum method conditions. Atazanavir sulfate eluted at 5.19 min without any interference. Method validation followed international guidelines. The method has proven linearity in the range of 10–90 µg mL−1. Recovery was between 100.2–101.0 % and precision within the accepted limits (RSD 0.2–0.7...
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关键词翻译
关键词翻译
  • sulfate 硫酸盐
  • quality 品质
  • analytical 分析的
  • approach 
  • suggested 建议
  • degrade 降低
  • conditions 条件式
  • validation 证实
  • design 设计
  • range 射程