| abstract |
The invention belongs to the field of analytical chemistry, and in particular relates to a method for determining carteolol hydrochloride and related substances in eye drops by ultra-high performance liquid chromatography. A chromatographic column with silica gel as filler, acetonitrile as mobile phase A and 0.282% sodium hexanesulfonate solution as mobile phase B as mobile phase, and gradient elution was performed. The method can not only completely separate and detect 9 known impurities contained in each pharmacopoeia at the same time, but also can separate and detect the starting materials and intermediates in the synthesis process of carteolol hydrochloride, especially 1,3-cyclohexanedione , 3-amino-2-cyclohexenone, can more simply, efficiently and accurately ensure the quality controllable of carteolol hydrochloride and its eye drops, and finally determine the safety of the product. |