氢溴酸沃替西汀原料药HPLC含量测定的方法学验证  

Validation of HPLC method for the determination of vortioxetine hydrobromide

作　　者：金慧 马燕 

机构地区：[1]上海市医药学校,200135 [2]南京斯贝源医药科技有限公司,南京市210000

出　　处：《临床合理用药杂志》2017年第4期73-75,共3页Chinese Journal of Clinical Rational Drug Use

摘　　要：目的建立高效液相色谱法(HPLC)测定氢溴酸沃替西汀原料药含量的方法。方法采用高效液相色谱法,色谱柱为Inert Sustain C18(4.6×250 mm,5μm)。流动相为10 m M磷酸二氢钾缓冲盐(p H=2.50)-乙腈(40∶60),流速为1.0 ml/min,柱温为30℃,检测波长为226 nm。含量测定采用外标法。结果样品中主峰与相邻杂质峰能较好分离,沃替西汀在0.32~0.48μg范围内线性关系良好,线性回归方程为Y=30931X+7.563(r=0.9998)。结论 HPLC外标法灵敏、准确、专属性好,可以用于氢溴酸沃替西汀原料药含量的测定。Objective To establish an HPLC method for determination of vortioxetine hydrobromide. Methods The HPLC was performed on InertSustain Cls column（4.6 × 250 mm ,5 μm） ,with mobile phase of 10mM monopotassium phosphate （pH = 2.50） -acetonitrile（40：60 ） at a flow rate of 1.0 ml/min. The column temperature was controlled on 30℃, and the wavelength was 226 nm. Results Under the above chromatographic condition,vortioxetine hydrobromide was completely sepa- rated from impurities. The calibrated linear curve of vortioxetine hydrobromide concentration was between 0.32 - 0.48 μg. The equation of linear regression was Y = 30931X ＋ 7. 563 （ r = 0.9998 ）. Conclusion This accurate and specific HPLC method can used to measure the concentration of vortioxetine hydrobromide.

关 键 词：高效液相色谱法 氢溴酸沃替西汀 含量测定 

分 类 号：R927.2[医药卫生—药学]