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目的建立同时测定Tegafur-Venenum Bufonis(FT-CS)胶囊中4种有效成分含量的方法,提高制剂的质量控制标准。方法采用HPLC法。色谱柱:Luna Phenyl-Hexyl柱(250 mm×4.6 mm,5μm);流动相:甲醇-水(体积比60∶40);流速:1.0 mL.min-1;柱温:40℃;检测波长:296 nm;进样量:10μL。结果蟾毒灵、脂蟾毒配基、华蟾毒精、替加氟能够达到基线分离;蟾毒灵质量浓度在1.1~21.0 mg.L-1内、脂蟾毒配基质量浓度在2.2~44.0 mg.L-1内、华蟾毒精质量浓度在2.0~40.0mg.L-1内、替加氟质量浓度在10.0~40.0 mg.L-1内与峰面积呈良好的线性关系;蟾毒灵、脂蟾毒配基、华蟾毒精、替加氟的回收率分别为98.05%、99.92%、100.02%、101.56%,RSD分别为2.52%、1.19%、0.43%、1.74%。结论该方法可作为FT-CS胶囊的质量控制方法之一。
Objective To establish a method for the simultaneous determination of four active ingredients in Tegafur-Venenum Bufonis (FT-CS) capsules and to improve the quality control standards of the preparation. Methods HPLC method. Column: Luna Phenyl-Hexyl column (250 mm × 4.6 mm, 5 μm); mobile phase: methanol-water (60:40 by volume); flow rate: 1.0 mL · min- 296 nm; injection volume: 10 μL. Results Bufalin, resibufogenin, canadonin and tegafur were able to achieve baseline separation. The concentration of bufalin was 1.1 ~ 21.0 mg.L-1, and the concentration of bufalotoxine was in the range of 2.2 ~ 44.0 mg.L-1, the concentration of bufadroxil in the range of 2.0-40.0 mg.L-1, the tebuconazole concentration in the range of 10.0-40.0 mg.L-1 showed a good linear relationship with the peak area; The recoveries of Toxin, Respogenin, Bufalin and Tegafur were 98.05%, 99.92%, 100.02% and 101.56%, respectively. The RSDs were 2.52%, 1.19%, 0.43% and 1.74%, respectively. Conclusion This method can be used as one of the quality control methods for FT-CS capsules.