RP-HPLC测定盐酸地芬尼多原料的有关物质

Determination of the Related Substances of Difenidol Hydrochloride by RP-HPLC

摘要: 目的建立高效液相色谱法测定盐酸地芬尼多原料有关物质的方法。方法采用VP-ODS C18色谱柱(250 mm×4.6 mm，5 μm)，以0.5%三乙胺溶液(用磷酸调pH至4.0)-甲醇(44∶56)为流动相；流速为0.8 mL·min-1；检测波长为210 nm，柱温：30 ℃。结果盐酸地芬尼多与有关物质及各降解成分完全分离，重复性及稳定性良好。最低检出限为1 ng。结论该方法操作简便、专属性强、灵敏度高、结果准确，可用于盐酸地芬尼多原料有关物质的检查。

Abstract: OBJECTIVE To establish an HPLC method for determination of related substances of difenidol hydrochloride. METHODS VP-ODS C18 column (250 mm 4.6 mm, 5 μm) was adopted. The mobile phase consisted of 0.5% triethylamine solution (adjusted to pH 4.0 with phosphoric acid)-methanol (44∶56) and the flow rate was 0.8 mL·min-1. The detection wavelength was 210 nm and the column temperature was 30 ℃. RESULTS Related substances and degraded substances were completely separated from difenidol hydrochloride. The method was good repeatability and stability. The LOD was 1 ng. CONCLUSION The method was selective, sensitive, accurate, and it is suitable for determination of related substances in difenidol hydrochloride.