| 引用本文: | 曹凤习，姜建国，刘红莉.RP-HPLC测定盐酸地芬尼多原料的有关物质[J].中国现代应用药学,2009,(8):661-664. |
| CAO Fengxi, JIANG Jianguo, LIU Hongli.Determination of the Related Substances of Difenidol Hydrochloride by RP-HPLC[J].Chin J Mod Appl Pharm(中国现代应用药学),2009,(8):661-664. |
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| 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。 |
| 关键词: 高效液相色谱法 盐酸地芬尼多原料 有关物质 |
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| Determination of the Related Substances of Difenidol Hydrochloride by RP-HPLC |
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CAO Fengxi, JIANG Jianguo, LIU Hongli
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| 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. |
| Key words: HPLC difenidol hydrochloride related substances |
