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-ODSC18色谱柱(250mm×4.6mm,5μm),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0.8mL·min-1;检测波长为210nm,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1ng。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。
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.
出处
《中国现代应用药学》
CAS
CSCD
北大核心
2009年第8期661-664,共4页
Chinese Journal of Modern Applied Pharmacy
