反相高效液相色谱法测定盐酸鲁拉西酮有关物质  

Determination of Related Substances in Lurasidone Hydrochloride by RP-HPLC

作　　者：张园园[1] 李银峰[2] 王杰晶[3] 李佩[1] 靳朝东[2] 

机构地区：[1]天津中医药大学研究生院,300193 [2]天津药物研究院分析测试中心,300193 [3]河南大学药学院,开封475001

出　　处：《医药导报》2013年第2期223-225,共3页Herald of Medicine

摘　　要：目的建立测定盐酸鲁拉西酮有关物质的反相高效液相色谱法。方法使用YMC-Pack Pro C18柱(150 mm×6.0 mm,5μm),流动相为甲醇-5 mmol.L-1磷酸氢二铵溶液[用稀磷酸调pH至7.0](85∶15),检测波长为230 nm,流速为1.0 mL.min-1。结果盐酸鲁拉西酮与中间体和降解产物在上述色谱条件下能有效分离,且在2.772～1 108.800μg.mL-1范围内线性关系良好(r=0.999 9)。结论该方法测定结果准确,操作简单,灵敏度高,专属性强,可用于盐酸鲁拉西酮的有关物质检查。Objective To determine the related substances in lurasidone hydrochloride by reversed phase high performance liquid chromatography （RP-HPLC） method. Methods YMC-Pack Pro Cls Column （150 min×6.0mm,5μm） was used. The mobile phase consisted of methanol-5 mmol·L^-1 diammonium phosphate [adjusted to pH 7.0 by phosphoric acid] （85 ： 15）. The detection wavelength was 230 nm, and the flow rate was 1.0 mL·min^-1. Results Lurasidone hydrochloride was effectively isolated from all of the intermediates and degradation products under this condition. The calibration curve of lurasidone hydrochloride was linear over the range of 2. 772-1 108.8 μg·mL^-1（r = 0. 999 9）. Conclusion The method was accurate, simple, rapid and exclusive, and could be applied for examination of related substances in lurasidone hydrochlorlde.

关 键 词：鲁拉西酮 盐酸 色谱法 高效液相 

分 类 号：R971.4[医药卫生—药品] R927.1[医药卫生—药学]