HPLC测定盐酸依替福辛胶囊含量及有关物质

Determination of Etifoxine Hydrochloride in Etifoxine Hydrochloride Capsules

目的建立用高效液相色谱法测定盐酸依替福辛胶囊含量及其有关物质的方法。方法色谱柱为Agilent TC-C18柱(4.6 mm×250 mm,5μm),流动相为甲醇-水(70∶30),流速1.0 mL·min-1,检测波长为254 nm。结果盐酸依替福辛在9～90 mg·L-1内线性关系良好(r=0.999 9),进样量为10μL,检出量分别为盐酸依替福辛1.0 ng,杂质A 3.3 ng,B4.0 ng,C 1.8 ng。平均回收率为99.82%,各杂质峰和主峰分离良好。结论方法简便、准确、专属,适用于盐酸依替福辛胶囊的质量控制。

OBJECTIVE To establish a HPLC method for the determination of etifoxine hydrochloride and its related substances in Etifoxine Hydrochloride Capsules. METHODS Methanol-water（70： 30）, the wavelength of detection was 254 nm. RESULTS The sample was separated on an Agilent TC-C18 column. The mobile phase consistend of a good linear relationship over was obtained the concentration range of 9 - 90 mg · L^-1 for etifoxine hydrochloride （ r = 0. 999 9）. The average recovery was 99. 82% . The detection limit of etifoxine hydrochloride and related substances A, B and C were respectively 1.0, 3. 3, 4. 0 and 1.8 ng. Etifoxine hydrochloride and its related substances were well isolated. CONCLUSION This method is simple and accurate. It could be applied to the determination of the Etifoxine Hydrochloride Capsules.