【摘要】 目的:建立伊潘立酮的含量及有关物质测定方法。方法:采用HPLC法,色谱柱:VP-ODS C18柱（150 mm×4.6 mm,5μm）;流动相:甲醇-0.1 mol·L^-1磷酸氢二铵溶液（用磷酸调pH至6.2±0.1）（65∶35）;流速:1.0 ml·min^-1;检测波长:275nm和228 nm;柱温:30℃;进样量:20μl。结果:本方法能较好地分离伊潘立酮及其有关物质,伊潘立酮在10.08¹00.80μg·ml^-1浓度范围内线性关系良好（r=0.999 8）,平均回收率为100.2%（RSD=0.82%,n=9）。结论:该方法灵敏快速、结果准确、重复性好,可用于伊潘立酮原料药的含量测定及有关物质检查。更多还原

【Abstract】 Objective:To establish an HPLC method for the determination of content and related substances of iloperidone.Methods:The separation was performed on a VP-ODS C18column（150 mm×4.6 mm,5 μm）.The mobile phase consisted of methanol-0.1 mol·L^-1ammonium phosphate solution（adjusting pH to 6.2 ± 0.1 with phosphoric acid）（65∶35）.The flow rate was 1.0 ml·min^-1and the detection wavelengths were 275 nm and 228 nm.The column temperature was 30 ℃ and the injection volume was 20μl.Results:The method could separate iloperidone and its related substances.Iloperidone had a good linear relationship within the range of 10.08-100.80 μg·ml^-1（r = 0.999 8）.The average recovery was 100.2% and RSD was 0.82%（n = 9）.Conclusion:The method is simple,quick,sensitive,accurate and repeatable,which can be used to determine the content and related substances of iloperidone.更多还原