HPLC法同时测定FT-CS胶囊中4种有效成分的含量

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。

Content determination of four components in FT-CS capsules by HPLC

Abstract：Objective To establish an HPLC method for the determination of the contents of Tegafur-Veneum Bufonis(FT-CS) capsules. Methods The separation was performed with a Luna Phenyl-Hexyl column（250 mm ×4.6 mm，5 µm）, and the mobile phase was CH3OH-H2O(V:V=60:40)with a flow rate of 1.0 mL·min-1and temperature was about 40 ℃, the wavelength of the detector was set at 296 nm and the injection volume was 10 μL. Results The average recovery of bufalin, resibufogenin, cinobufagin and tegafur were 98.05 %, 99.92 %, 100.02 % and 101.56 %, with RSD of 2.52 %, 1.19 %, 0.43 % and 1.74 %, respectively. The calibration curve were linear throughout the range of 1.1-21.0 mg·L-1，2.2-44.0 mg·L-1,2.0-40.0 mg·L-1 and 10.0-40.0 mg·L-1, respectively. Conclusions This method is applicable for the determination of content of FT-CS capsules.