| AIM:To establish a hydrophilic interaction liquid chromatography-mass spectrometry (HILIC-MS) method for the determination of related substances in Pramipexole Dihydrochloride. METHODS:The HPLC(high performance liquid chromatography) conditions were as follows:Merck ZIC-HILIC HPLC Column (150*4.6mm I.D),5μm. Mobile phase was ammonium acetate sodium perchloeate-acetonitrile (0.01%with Glacial acetic acid). The flow rate was1.5mL·min-1. The detection wavelength was at264nm. Injection sample amount was5μL. RESULTS:The LOD was3.16ng and the LOQ was10ng of substance A, The LOD was1.58ng and the LOQ was4ng of substance B. CONCLUSION:The developed HILIC-MS method was rapid, simple, accurate and reproducible. This method is can be used for the determination of related substances in Pramipexole Dihydrochloride. |
PDF Full Text Request