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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10.08~100.80μg·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。
Objective: To establish the content of iloperidone and the determination of related substances. Methods: The mobile phase was methanol-0.1 mol·L -1 diammonium phosphate (adjusted to pH 6.2 with phosphoric acid) by HPLC on a VP-ODS C18 column (150 mm × 4.6 mm, 5 μm) ± 0.1) (65:35); flow rate: 1.0 ml · min -1; detection wavelength: 275 nm and 228 nm; column temperature: 30 ℃; injection volume: 20 μl. Results: The method was able to separate iloperidone and its related substances well. The linearity of iloperidone was in the range of 10.08-100.80μg · ml -1 (r = 0.999 8), and the average recoveries Was 100.2% (RSD = 0.82%, n = 9). Conclusion: The method is sensitive, rapid, accurate and reproducible. It can be used to determine the content of iloperidone and related substances.