目的 建立伊潘立酮片的有關(guān)物質(zhì)測定方法，與參比制劑進行有關(guān)物質(zhì)一致性評價研究。方法 建立高效液相色譜法（HPLC）測定伊潘立酮片有關(guān)物質(zhì)，并考察方法的專屬性、線性、精密度、準(zhǔn)確性及耐用性等。采用Agela Venusil MP C₁₈（150 mm×4.6 mm，5 μm）色譜柱，以0.02 mol/L磷酸氫二銨緩沖液（磷酸調(diào)pH至7.0±0.1）為流動相A，以乙腈為流動相B，體積流量1.0 mL/min，檢測波長為229 nm，柱溫40℃。結(jié)果 在選定的色譜條件下，伊潘立酮與雜質(zhì)分離良好，輔料無干擾。自研伊潘立酮片與參比制劑雜質(zhì)譜相似。結(jié)論 該方法準(zhǔn)確、可靠、耐用性好，自研伊潘立酮片與參比制劑具有有關(guān)物質(zhì)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.