摘要
目的建立特非那定片的有关物质高效液相色谱检查法(HPLC)。方法采用HPLC法,使用Hypersil Phenyl 2(250×4.6mm,5μm)色谱柱,流动相为缓冲液-乙腈-三乙胺(650∶350∶3;检测波长为220nm;流速为1.5mL·min-1;柱温为室温。结果该色谱条件下,杂质与主成分能完全分离,重复性试验RSD为0.27%(n=6),最低检测量为0.005μg,有关物质含量均为0.3%。结论该方法简便、准确、灵敏度高,可用于特非那定片中杂质含量的测定。
OBJECTIVE To establish an HPLC method for related substances of Terfenadine tab- lets. METHODS The related substances of terfenadine were detemined on the HPLC instrument using a Hypersil Phenyl 2 column. The mobile phase consisted of buffer-acetomitrile-triethylamine （650：350：3） with flow rate of 1.5mL ~ min-1. The detection wavelength was set at 220nm and the column temperature was maintained at room temperature. RESULTS Terfenadine could be completely separated from all related substances completely and the constituent The precision RSD of this analytical method was 0. 27% （n = 6）. The limits of detection were 0. 005μg and the contents of related substances were 0. 3 %. CONCLUSION The method is simple, rapid, accurate and suit- able for the determination of related substances in Terfenadine tablets.
出处
《海峡药学》
2013年第9期89-91,共3页
Strait Pharmaceutical Journal
