高效液相色谱法测定茴三硫片的有关物质

Determination of Related Substance in Anethole Trithione Tablets by HPLC

目的建立用HPLC测定茴三硫片中茴三硫有关物质的方法。方法用Agilent XDBC18色谱柱(4.6 mm×150 mm,5μm);流动相:甲醇-水(80∶20),检测波长351 nm,柱温35℃,流速1.0 mL/min,进样量10μL。结果在此色谱条件下,茴三硫有关物质与主药有效分离,检测限0.12 ng(S/N≥3)。结论本方法简便、准确、耐用性良好,可用于茴三硫片中茴三硫有关物质的检测。

Objective To establish an HPLC method for the determination of related substance in anethole trithione tablets. Methods An Agilent XDBC18 column （4.6 mm× 150 mm, 5μm） was used. The mobile phase consisted of methanol-water （80 ： 20）. The flow rate was 1.0 mL/min. The detection wavelength was set at 351 nm and the chromatography was operated at 35 ℃. The injection volume was 10 μL. Results An effective resolution between the main peak and impurity peak was obtained. The limit of detection was 0.12 ng （S/N≥ 3）. Conclusion The method is simple, accurate and has good durability. It is suitable for determining the related substance in anethole trithione tablets.