摘要
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：LunaPhenyl-Hexyl柱（250mm×4．6mm，5μm）；流动相：甲醇-水（体积比60：40）；流速：1．0mL·min-1；柱温：40℃；检测波长：296nm；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1．1～21．0mg·L^-1内、脂蟾毒配基质量浓度在2．2—44．0mg·L“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—40．0mg·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FF-CS胶囊的质量控制方法之一。
Objective To establish an HPLC method for the determination of the contents of Tegafur-Venenum Bufonis（FT-CS） capsules. Methods The separation was performed with a Luna Phenyl-Hexyl column （250 mm × 4.6 mm, 5μm）, and the mobile phase was CH3OH-H2O （ V： V = 60： 40 ） with a flow rate of 1.0 mL. min^- 1 and 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.
出处
《沈阳药科大学学报》
CAS
CSCD
北大核心
2009年第2期123-126,共4页
Journal of Shenyang Pharmaceutical University
