摘要
目的:建立高效液相色谱测定盐酸文拉法辛缓释胶囊有关物质的方法。方法:采用Venusil XBP C18色谱柱(250 mm×4.6 mm,5μm),流动相为乙腈-1%三乙胺溶液(取三乙胺10 mL,加水稀释至1000 mL,用磷酸调节pH至3.0)(28∶72),流速为1.0 mL·min-1,检测波长为226 nm,柱温为30℃。结果:盐酸文拉法辛与有关物质分离良好,辅料不干扰测定,线性工作曲线为Y=46.776X+0.4435,r=1.0000,最低检测限12.67 ng·mL-1,定量限为44.84 ng·mL-1,回收率为99.4%(n=9)。结论:本方法操作简便准确,灵敏度高,适用于盐酸文拉法辛缓释胶囊有关物质检查。
Objective ： To establish an HPLC method for the determination of related substances of venlafaxine hydrochloride sustained-release capsules. Methods： Venusil XBP C18 column（250 mm ×4.6mm,5μm）was used and the mobile phase was composed of 1 volume of triethylamine,28 volumes of acetonitrile and 72 volumes of water adjusted to pH 3.0 with orthophosphoric acid. The flow rate was 1.0 mL·min^-1, the detection wavelength was 226 nm,and the column temperature was 30 ℃. Results：Venlafaxine hydrochloride and related substances could be baseline separated,and the excipients didn＇t interfere with the determination. The Delta standard curve equation was Y = 46. 776X ＋ 0. 443 5 （ r = 1. 000 0）. The detection limit was 12.67 ng·mL ^- 1, and the limit of quantification was 44.84 ng·mL ^- 1 The average recoveries were 99.4% （ n = 9）. Conclusion： This method is rapid, accurate and sensitive and can be used for determination of the content and related substances of venlafaxine hydrochloride sustained-release capsules.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2014年第11期1311-1315,1320,共6页
Chinese Journal of New Drugs
