摘要
目的：建立测定依托贝特原料有关物质的HPLC方法.方法：色谱柱为Thermo C18（250 mm×4.6mm,5μm）;流动相：乙腈-0.05 mol·L-1醋酸铵（50：50）用冰醋酸调pH为4.5;流速：1.0 ml·min-,检测波长：238 nm,柱温：25℃,进样量：10μl.结果：依托贝特的线性范围为0.102～1.536μg·ml-1,r=1.000 0;各杂质峰与主峰分离度良好,检出限及定量限分别为6.25 ng及20.83 ng.结论：该方法灵敏度高、精密度好、专属性强,可用于依托贝特原料有关物质的检查.
Objective： To establish a determination method for the related substances in the raw material of etofibrate by HPLC. Methods： A Thermo C ls （250 mm × 4.6 mm, 5 μm） column was adopted with the mobile phase consisting of acetonitrile-0.05 mol · L-1 ammonium acetate （50：50） （adjusting pH to 4.5 with glacial acetic acid）. The flow rate was 1.0 ml · min-1, the detection wavelength was set at 238nm, the column temperature was 25℃ and the injection volume was 10 μl. Results： The linear range of etof- ibrate was 0. 102-1. 536 μg ·m1-1 （ r = 1. 000 0）. The resolution of the related substances was acceptable. The limit of detection and the quantitative limit was 6.25ng and 20.83ng, respectively. Conclusion： The method is sensitive, accurate and specific in the deter- mination of the related substances in the raw material of etofibrate.
出处
《中国药师》
CAS
2014年第8期1313-1315,共3页
China Pharmacist
