利用QbD理念进行埃索美拉唑钠杂质检测方法的研究

Studies on Impurity Detection Method of Esomeprazole sodium by QbD Principles

目的利用质量源于设计(Qb D)的理念进行埃索美拉唑钠杂质研究,并论述了基于上述理念进行的杂质检测方法开发的过程。方法色谱柱为安捷伦Zorbax Extend C18(250mm×4.6mm,5μm),流动相采用乙腈-磷酸盐缓冲液(p H 7.6)-水梯度洗脱,流速1.0m L·min-1,柱温:40℃,检测波长:280nm与265nm。结果本方法能有效检测到利用Qb D预测的各个杂质,方法灵敏度高,专属性好,准确度佳。结论利用Qb D理念指导埃索美拉唑钠杂质研究,能真实有效的反应产品的杂质水平,避免杂质检测不全。

OBJECTIVE To establish a impurity detection method of esomeprazole sodium by using Quality by Design（ Qb D） principles. METHODS Agilent Zorbax Extend C18（ 4. 6mm × 250 mm,5μm） was used with acetonitrile-phosphate buffer（ p H 7. 6）-Water as the mobile phase,at the flow rate of 1. 0m L·min^- 1. The column temperature was set at 40℃,The detection wavelength was 280 nm and 265 nm. RESULTS The method could effectively detected the impurities predict by the Qb D principles with high sensitivity,good specificity and accuracy. CONCLUSION Impurities study using Qb D principles can truly and effective response the esomeprazole sodium＇s quality,and avoiding impurity detection insufficiency.