HPLC法测定盐酸普拉克索缓释片中的有关物质  

Determination of the Related Substances in Pramipexole Dihydrochloride Sustained-release Tablets by HPLC

作　　者：王建科 周灵利 卢柳璇 陈维维 袁德彬 华阳丽 吴大颖 苟旭洲 陈诗阳 柯潇[1] WANG Jian-ke;ZHOU ling-li;LU Liu-xuan;CHEN Wei-wei;YUAN De-Bin;HUA Yang-Li;WU Da-Ying;GOU Xu-zhou;CHEN Shi-yang;KE Xiao(Chengdu Kanghong Pharmaceutical Group Co.Ltd.,Chengdu 610036,China)

机构地区：[1]成都康弘药业集团股份有限公司,四川成都610036

出　　处：《海峡药学》2020年第9期81-86,共6页Strait Pharmaceutical Journal

摘　　要：目的建立盐酸普拉克索缓释片的有关物质的检查方法。方法采用HPLC法测定,色谱柱为Inertsil ODS3-C18(150×4.6mm,3μm);以流动相A:甲酸铵溶液(取甲酸铵18.9g,加水1000mL使溶解,用甲酸调节pH值5.0)和流动相B:甲醇-甲酸铵溶液(55∶45)进行梯度洗脱,流速为0.8mL·min^-1,柱温35℃,检测波长分别240nm,262nm与326nm。结果盐酸普拉克索与有关物质杂质J、杂质K、杂质I、杂质L、杂质G与杂质H能有效分离,分离度均大于5.8。有关物质杂质J、杂质K、杂质G、杂质L、杂质H与杂质I分别在0.0240~0.2877μg·mL^-1、0.0242~0.2899μg·mL^-1、0.0240~0.2876μg·mL^-1、0.0247~0.2969μg·mL^-1、0.0258~0.3091μg·mL^-1、0.0237~0.2846μg·mL^-1内与峰面积呈良好的线性关系,回收率分别为97.3%、106.7%、94.5%、93.1%、94.1%、99.5%。结论所用方法简便、快速、灵敏,该方法适用于盐酸普拉克索缓释片中有关物质的检测。OBJECTIVE To establish a determinate method of the related substances in Pramipexole dihydrochloride sustained-release tablets METHODS The chromatography analysis was performed on a Inertsil ODS3-C18 column(150×4.6 mm,3μm).The mobile phase composed of Ammonium formate solution(18.9 g ammonium formate in 1000 mL water,adjusted to pH 5.0 by formic acid)(A)and methanol-Ammonium formate solution(55∶45)(B)in gradient elution at a rate of 0.8 mL·min^-1.The detection wavelength was 240 nm,262 nm and 326 nm.The column temperature was 45℃.RESULTS The related substances of Impurity-J,Impurity-K,Impurity-I,Impurity-L,Impurity-G,Impurity-H and pramxoline in compound preparations were well separated.They had good linear relationship especially in the ranges of 0.0240-0.2877μg·mL^-1,0.0242-0.2899μg·mL^-1,0.0240-0.2876μg·mL^-1,0.0247-0.2969μg·mL^-1,0.0258-0.3091μg·mL^-1 and 0.0237-0.2846μg·mL^-1.The average recoveries especially were 97.3%,106.7%,94.5%,93.1%,94.1%and 99.5%.CONCLUSION The method is simple,rapid,highly sensitivite and have a good specificity,which can be used to control the related substances in pramipexole dihydrochloride sustained-release tablets.

关 键 词：高效液相色谱法 盐酸普拉克索缓释片 有关物质 

分 类 号：R927[医药卫生—药学]