目的建立HPLC测定盐酸多巴酚丁胺葡萄糖注射液中的有关物质及含量测定的方法。方法采用岛津VP-ODSC₁₈柱(4.6 mm×150 mm,5μm);A相(0.014 mol·L^-1磷酸铵缓冲液,用磷酸调pH为2.3)-B相(乙腈)为流动相;流速:1.0 mL·min^-1;梯度洗脱;检测波长为280 nm;柱温为室温。结果盐酸多巴酚丁胺和5-羟甲基糠醛及其他有关物质分离度良好,盐酸多巴酚丁胺和5-羟甲基糠醛的定量限分别为4和0.1 ng。结论本法简便、准确、专属性好,灵敏度高,可用于盐酸多巴酚丁胺葡萄糖注射液中盐酸多巴酚丁胺及5-羟甲基糠醛等有关物质的检查。

OBJECTIVE To establish a HPLC method for determining the content of 5-hydroxymethylfurfural(5-HMF) and other related compounds in Dobutamine Hydrochloride and Glucose Injection.METHODS The HPLC method was performed on a SHISEIDO VP-ODS C₁₈ column(4.6 mm×150 mm,5 μm)and coupled with UV detecter at 280 nm.The mobile phase consisted of 0.014 mol·L^-1(NH₄)₃PO₄ buffer(adjusted to pH 2.3 with phosphoric acid) and acetonitrile with gradient elution program.The flow rate was 1.0 mL·min^-1 and the column temperature was room temperature.RESULTS The resolution between Dobutamine Hydrochloride,5-HMF and other related compounds was satisfied,and the LOQ of Dobutamine Hydrochloride and 5-HMF were 4 and 0.1 ng,respectively.CONCLUSION A simple,accurate and sensitive HPLC method for determining the content of 5-HMF and other related compounds in Dobutamine Hydrochloride and Glucose Injection was established.