盐酸多巴酚丁胺葡萄糖注射液含量测定和5-羟甲基糠醛等有关物质检查方法的建立  

Determination of 5-HMF and Other Related Compounds in Dobutamine Hydrochloride and Glucose Injection by HPLC

作　　者：岳志华[1] 张娜[1] 李慧义[1] 

机构地区：[1]中国药品生物制品检定所,北京100050

出　　处：《中国药学杂志》2008年第21期1661-1664,共4页Chinese Pharmaceutical Journal

摘　　要：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 ram,5 μm）and coupled with UV detecter at 280 nm. The mobile phase consisted of 0. 014 mol · L^-1 （ NH4 ）3PO4buffer（ 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.

关 键 词：高效液相色谱法 盐酸多巴酚丁胺葡萄糖注射液 5-羟甲基糠醛 有关物质 

分 类 号：R917[医药卫生—药物分析学]