HPLC法测定伊潘立酮的含量及有关物质  

Determination of Content and Related Substances of Iloperidone by HPLC

作　　者：杨瑜[1] 

机构地区：[1]武汉大学中南医院药学部,武汉430071

出　　处：《中国药师》2016年第12期2355-2357,共3页China Pharmacist

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10.08~100.80μg·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 an HPLC method for the determination of content and related substances of iloperidone. Methods： The separation was performed on a VP-ODS Cls column （150 mm ×4.6 mm, 5 μm）. The mobile phase consisted of methanol- 0.1 mol · L^-1 ammonium phosphate solution （ adjusting pH to 6.2 ± 0.1 with phosphoric acid ） （65 ： 35 ）. The flow rate was 1.0 ml · min^-1 and the detection wavelengths were 275 nm and 228 nm. The column temperature was 30 ℃ and the injection volume was 20 μl. 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.

关 键 词：伊潘立酮 含量 有关物质 高效液相色谱法 

分 类 号：R927.2[医药卫生—药学]