反相高效液相色谱法测定盐酸左旋米那普仑原料药中多种杂质  

Determination of Multi-Impurities of Levomilnacipran Hydrochloride Raw Material by RP-HPLC

作　　者：周灵利 陈维维 张启余[1] 柯潇[1] ZHOU Lingli;CHEN Weiwei;ZHANG Qiyu;KE Xiao(Chengdu Kanghong Pharmaceutical Group Co.,Ltd.,Chengdu 610037,China)

机构地区：[1]成都康弘药业集团股份有限公司

出　　处：《成都大学学报（自然科学版）》2019年第4期371-374,共4页Journal of Chengdu University（Natural Science Edition）

摘　　要：建立盐酸左旋米那普仑原料药有关物质测定的反相高效液相色谱法.色谱柱为Waters sunfire C18(5μm,250 mm×4.6mm);以0.05%TFA水溶液为流动相A,0.05%TFA乙腈溶液为流动相B,进行梯度洗脱;检测波长为220 nm;流速为1.0 mL/min;柱温为30℃;进样体积10μL.盐酸左旋米那普仑与有关物质(含降解产物)分离度良好,且能同时控制极性小的工艺杂质和极性大的降解杂质.方法简便快速、准确灵敏、重复性好,能够用于盐酸左旋米那普仑有关物质测定.The paper is going to establish a RP-HPLC method for the determination of the related impurities of the Levominacipran Hydrochloride material.Waters sunfire C 18(5μm,250 mm×4.6 mm)column was used.The mobile phase with water(0.05%TFA)served as the mobile phase A and the one with acetonitrile(0.05%TFA)as the mobile phase B.Gradient elution was used.The detective wavelength was 220 nm.The flow rate was 1.0 mL/min.The column temperature was set at 30℃.The injection volume was 10μL.Levomilnacipran hydrochloride was well separated from the related impurities(including degradation products).The results show that this method can separate weak polar process impurities and strong polar degradation impurities as well.It is concluded that the method with a good repeatability is sensitive,exclusive,accurate and suitable for the determination of the related impurities of the levomilnacipran hydrochloride material.

关 键 词：高效液相色谱法 盐酸左旋米那普仑 有关物质 

分 类 号：R971.43[医药卫生—药品]