HPLC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：周益芬 林楠[2] 宋光华[2] 严莉容 朱江[2] 吴红丽[2] 柯潇[2] 邬智刚 

机构地区：[1]四川省食品药品检验检测院,四川成都611731 [2]成都康弘药业集团股份有限公司,四川成都610036

出　　处：《华西药学杂志》2015年第2期245-246,共2页West China Journal of Pharmaceutical Sciences

摘　　要：目的采用HPLC法测定盐酸普拉克索缓释片中的有关物质。方法采用Waters Sunfire C18色谱柱,以0.1 mol·L^-1乙酸铵（p H5.0,含0.1%三乙胺）-甲醇（98∶2）为流动相A,以甲醇为流动相B,梯度洗脱,检测波长264、326 nm,柱温40℃,流速1.0 mL·min^-1。结果高、中、低浓度杂质的平均回收率为90.5%-105.8%（n=9）;最低检出限为0.15-0.60 ng。结论所用方法简便、快速、灵敏,可用于检测盐酸普拉克索缓释片中的有关物质。OBJECTIVE To detect the related substances in Pramipexole dihydrochloride sustained -release tablets by HPLC. METHODS The analysis was carried out on the Waters Sunfire Cls column. The mobile phase composed of 0.1 mol·L^-1 ammonium acetate （ pH5.0,0.1% trithylamine） - methanol （ 98 ： 2 ） （A） and methanol （B） in gradient elution at a flow rate of 1.0 mL·min^-1. And the detection wavelength was 264 nm and 326 nm, The column temperature was 40℃. RESULTS The linear range of all the related substanc, es was 0.02 -0.3 μg· mL^-1. The average recovery was 90.5% - 105.8%. The LOD was 0.15 -0.60 ng. CONCLU- SION The method is simple, specific, sensitive for determination of the related substances in Pramipexole dihydrochloride sustained - release tablets.

关 键 词：有关物质 亲水凝胶骨架缓释片 高效液相色谱法 盐酸普拉克索 

分 类 号：R917[医药卫生—药物分析学]