目的 建立氫溴酸沃替西汀片的體外溶出度測(cè)定方法，分析體外釋放行為。方法 建立高效液相色譜法測(cè)定氫溴酸沃替西汀片溶出度的方法，并考察方法的專屬性、線性、精密度、準(zhǔn)確性及濾膜干擾。Waters Symmetry C₁₈色譜柱（250mm×4.6 mm，5 μm），以水/三氟乙酸混合溶液（1 000∶0.5）為流動(dòng)相A，甲醇-乙腈-水-三氟乙酸混合溶液（600∶350∶50∶0.35）為流動(dòng)相B，流動(dòng)相A與流動(dòng)相B比例為45∶55，體積流量1.0 mL/min，檢測(cè)波長(zhǎng)為254 nm，柱溫40℃。結(jié)果 在上述色譜條件下，氫溴酸沃替西汀與其同分異構(gòu)體分離良好。試驗(yàn)專屬性、線性、精密度、準(zhǔn)確性良好，所使用濾膜對(duì)結(jié)果測(cè)定無(wú)干擾。結(jié)論 該方法準(zhǔn)確、可靠、耐用性好，可為氫溴酸沃替西汀片的質(zhì)量控制提供參考依據(jù)。

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.