HPLC法测定人血清中氢溴酸伏硫西汀的浓度

Determination of Vortioxetine Hydrobromide in Human Serum by HPLC

目的建立HPLC法检测人血清中氢溴酸伏硫西汀的浓度。方法采用Shim-pack GIST C18(150 mm×4.6 mm,5μm)色谱柱;流动相:10 mmol·L^(-1)醋酸铵(pH 6.5)-乙腈(67∶33);流速:1.0 ml·min^(-1);柱温:30℃;检测波长:226 nm。以乙醚为提取剂。结果氢溴酸伏硫西汀血药浓度在25~500 ng·ml^(-1)线性关系良好,线性方程为Y=0.007 X-0.013(r=0.9996),方法回收率为96.93%~103.77%,提取回收率为95.19%~99.98%;日内、日间精密度均小于15%。结论该方法灵敏、简单、快速、准确,可用于临床氢溴酸伏硫西汀血药浓度监测并促进其在临床的合理使用。

Objective To establish an HPLC method for determination of vortioxetine hydrobromide in human serum.Methods The content of vortioxetine hydrobromide in serum was analyzed in a reverse phase HPLC system Shim-pack GIST C18(150 mm×4.6 mm,5μm).The mobile phase consisted of 10 mmol·L^(-1) acetate amine(pH 6.5)-acetonitrile(67∶33),the flow rate was 1.0 ml·min^(-1),the column temperature was 30℃and the detection wavelength was at 226 nm.Ether was used as the extracting solvent.Results The calibration curve was linear within the range of 25 to 500 ng·ml^(-1) for vortioxetine hydrobromide while the regression equation was Y=0.007 X-0.013(r=0.9996).The relative recovery rate ranged from 96.93%to 103.77%and the absolute recovery rate ranged from 95.19%to 99.98%.The intra-day and inter-day variations(RSDs)were both lower than 15%.Conclusion This method is sensitive,simple,rapid and accurate,can be used to monitor the serum concentration of vortioxetine hydrobromide and promote its rational use in clinic.