摘要
目的:基于质量源于设计(QbD)理念,建立并优化恩曲他滨替诺福韦片的分析方法。方法:以主峰与杂质峰之间分离度为评价指标,采用Plackett-Burman设计在风险评估的基础上筛选出关键质量属性(CMAs)及关键质量参数(CMPs),根据试验结果进行Box-Behnken试验设计,建立控制空间,并对最佳优化条件进行了验证。结果:从控制空间内选择的优化条件,可以对各杂质进行有效分离和检出。结论:优化过的分析方法适用于恩曲他滨替诺福韦片有关物质测定,为QbD在药品分析领域中的应用提供了新的思路和参考。
Objective:To establish and optimize a HPLC analysis method for Emtricitabine and tenofovir disoproxil fumarate tablets based on the concept of quality by design(QbD).Methods:The resolution between the main peak and impurity peak were taken as the analytical target profile,Plackett-Burman design(PBD)method was used to select critical method parameters and critical method attributes on the basis of risk assessment.Based on the test results,conduct a Box Behnken design and establish a control space,And the optimized method were verified.Results:optimized method from the control space can effectively separate and simultaneously detect various Related substances.Conclusion:The optimized method can be used for the analysis of Emtricitabine and tenofovir disoproxil fumarate tablets,so the QbD concept can provide new thoughts and references in the pharmaceutical analysis.
作者
黄德见
唐嘉悦
张亚丽
De jian;TANG Jia yue;ZHANG Ya li(Anhui Biochem Bio-pharmaceutical Co.,Ltd.,AnHui Hefei 230088,China)
出处
《北方药学》
2023年第6期1-4,共4页
Journal of North Pharmacy
