Method for separating and detecting terbutaline sulfate injection and impurities thereof

The invention belongs to the technical field of medicine detection, and particularly relates to a method for separating and detecting terbutaline sulfate injection and impurities thereof. Comprising the following steps: carrying out gradient elution by adopting a mobile phase A and a mobile phase B by adopting an HPLC (High Performance Liquid Chromatography) method and taking octadecyl bonded silica gel as a filler, and detecting in a detector; the impurity is 3, 5-dihydroxy benzaldehyde, and the mobile phase A is a mixed solution of perchlorate and phosphate; the mobile phase B is methanol. The detection method is strong in specificity, high in precision, good in accuracy, convenient to operate and capable of effectively controlling medicine quality. 本发明属于医药检测技术领域，具体涉及一种分离检测硫酸特布他林注射液及其杂质的方法。包括如下步骤：采用HPLC法，以十八烷基键合硅胶为填料，采用流动相A和流动相B进行梯度洗脱，进入检测器进行检测；所述杂质为3，5-二羟基苯甲醛，其中，所述流动相A为高氯酸盐与磷酸盐的混合溶液；流动相B为甲醇。该检测方法专属性强、精密度高、准确性好、操作方便，可有效控制药品品质。