摘要
目的:建立测定依非韦伦片中三种难分离的特定杂质含量的方法。方法:采用Waters Symmetry C_(18)柱(4.6 mm×250 mm,5μm),以水-乙腈-三氟乙酸为流动相梯度洗脱,检测波长为250 nm,流量为1.5 m L·min^(-1)。结果:三种特定杂质峰与主峰间的分离度良好,最低检测限为0.5 ng,依非韦伦浓度在0.125~2.5μg·m L^(-1)范围内与峰面积呈良好的线性关系(r=0.999 9,n=6)。结论:本方法简便,专属性强,可用于依非韦伦片中三种特定杂质的控制。
Objective： To establish an HPLC method for the determination of content of three specified impurities in Efavirenz Tablets. Method： A Waters Symmetry Cls column （4. 6 mm ×250 mm,5 μm） was adopted. The mobile phase was water-aeetonitrile-trifluoroacetic acid system with gradient elution. The detection wavelength was 250 nm and the flow rate was 1.5 mL · min-1. Results：The resolution of Efavirenz and its specified impurities was good, the limit of detection was 0. 5 ng. The linear range of Efavirenz was O. 125 - 2. 5 μg· mL - 1 （ r = 0. 999 9, n = 6）. Conclusion ： The method is convenient and specific which can be used to control the content of three specified impurities in Efavirenz Tablets.
出处
《中国药品标准》
CAS
2015年第5期356-358,共3页
Drug Standards of China
