目的 建立伊潘立酮片的有关物质测定方法，与参比制剂进行有关物质一致性评价研究。方法 建立高效液相色谱法（HPLC）测定伊潘立酮片有关物质，并考察方法的专属性、线性、精密度、准确性及耐用性等。采用Agela Venusil MP C₁₈（150 mm×4.6 mm，5 μm）色谱柱，以0.02 mol/L磷酸氢二铵缓冲液（磷酸调pH至7.0±0.1）为流动相A，以乙腈为流动相B，体积流量1.0 mL/min，检测波长为229 nm，柱温40℃。结果 在选定的色谱条件下，伊潘立酮与杂质分离良好，辅料无干扰。自研伊潘立酮片与参比制剂杂质谱相似。结论 该方法准确、可靠、耐用性好，自研伊潘立酮片与参比制剂具有有关物质一致性。

Objective To establish high performance liquid chromatography (HPLC) methods for determination of related substances in Iloperidone tablets.Methods The related substances were determined on a Agela Venusil MP C₁₈ column (150 mm×4.6 mm, 5 μm), Mobile phase A:0.02 mol/L diammonium hydrogen phosphate buffer (adjust pH value to 7.0 with phosphoric acid), mobile phase B:acetonitrile, The flow rate was 1.0 ml/min and the detection wavelength was 229 nm, column temperature was 40℃. Results Under the chromatographic conditions, the resolution of Iloperidone and related substances was great, and excipients without interference. The related substances of reference preparation and self-preparation have significant similarity. Conclusion The method is accurate, reliable and durable, and the related substances of the two preparations are similar.