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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 a HPLC method for the determination of related substances of dendrolimus hydrochloride. Methods The mobile phase was VP-ODSC18 column (250 mm × 4.6 mm, 5 μm) with 0.5% triethylamine (adjusted to pH 4.0 with phosphoric acid) -methanol (44:56). The flow rate was 0.8 mL · min -1 ; Detection wavelength was 210nm, column temperature: 30 ℃. Results of diphenhydramine hydrochloride with the relevant substances and the complete separation of the degradation components, reproducibility and good stability. The minimum detection limit is 1ng. Conclusion The method is simple, specific, sensitive and accurate. It can be used for the determination of related substances of phenanthridine hydrochloride.