氢溴酸沃替西汀片溶出度测定方法学研究  

Study on dissolution determination of Vortioxetine Hydrobromide Tablets

作　　者：华东东 米楠[1] 臧可昕[1] 阎卉[1] 房思萌[1] HUA Dongdong;MI Nan;ZANG Kexin;YAN Hui;FANG Simeng(Tianjin Pharmaceutical Research Institute Co.,LTD, Tianjin 300193, China)

机构地区：[1]天津药物研究院,天津300193

出　　处：《药物评价研究》2018年第11期2011-2014,共4页Drug Evaluation Research

摘　　要：目的建立氢溴酸沃替西汀片的体外溶出度测定方法,分析体外释放行为。方法建立高效液相色谱法测定氢溴酸沃替西汀片溶出度的方法,并考察方法的专属性、线性、精密度、准确性及滤膜干扰。Waters Symmetry C18色谱柱(250mm×4.6 mm,5μm),以水/三氟乙酸混合溶液(1 000∶0.5)为流动相A,甲醇-乙腈-水-三氟乙酸混合溶液(600∶350∶50∶0.35)为流动相B,流动相A与流动相B比例为45∶55,体积流量1.0 mL/min,检测波长为254 nm,柱温40℃。结果在上述色谱条件下,氢溴酸沃替西汀与其同分异构体分离良好。试验专属性、线性、精密度、准确性良好,所使用滤膜对结果测定无干扰。结论该方法准确、可靠、耐用性好,可为氢溴酸沃替西汀片的质量控制提供参考依据。Objective To establish a method for determining the dissolution of Vortioxetine hydrobromide tablets and analyze the dissolution behavior in vitro. Methods To establish HPLC determination method for the dissolution of Vortioxetine hydrobromide tablets and verify the specificity, linearity, precision, accuracy, membrane filter interference. Chromatographic separation was achieved on an Octa Decyl Silyl column(Waters Symmetry■ C18, 150 mm × 4.6 mm ID, 5 μm particle); Mobile phase A: water –trifluoroacetic acid(1 000 : 0.5), mobile phase B: methyl alcohol-acetonitrile-water-trifluoroacetic acid(600:350:50:0.35). The flow rate was 1.0 mL/min and the detection wavelength was 254 nm, column temperature was 40℃. Results Under the chromatographic conditions, the resolution of Vortioxetine hydrobromide and structural isomer was great, the specificity, linearity,precision, accuracy of the method was good, the membrane filter didn’t affect the results, Conclusion The method is accurate,reliable and durable, and can be used in the quality control of Vortioxetine hydrobromide tablets.

关 键 词：氢溴酸沃替西汀片 溶出度 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]