HPLC法测定苯扎贝特酰化物中的有关物质  

Related substances determination of bezafibrate acylate by HPLC

作　　者：黄东[1] 吴保祥[1] 王昉[2] 

机构地区：[1]江苏天士力帝益药业有限公司,江苏淮安223002 [2]南京师范大学分析测试中心,江苏南京210046

出　　处：《中国医药科学》2014年第9期118-120,123,共4页China Medicine And Pharmacy

基　　金：江苏省高校自然科学研究基金项目(09KJD350001)

摘　　要：目的建立苯扎贝特酰化物中有关物质的测定方法。方法 NUCLEOSIL 100-5 C18(5μm)0.125m×4mm;流动相为磷酸二氢钾溶液(2.72g/L,用磷酸调节pH2.3)︰甲醇=4︰6;检测波长:228nm;流速:1.0mL/min。结果苯扎贝特酰化物与主要杂质能得到有效分离,各杂质在0.2~3.5μg/mL范围内呈良好线性关系。结论本测定方法灵敏度高,准确可靠,可以控制苯扎贝特酰化物中有关物质的含量。Objective To establish an HPLC method for detection of the related substances. Methods The analytical column was NUCLEOSIL 100-5 C18 column (4.0mm×12.5cm, 5μm). The mobile phase was potassium dihydrogen phosphate (2.72g/L, adjust to pH 2.3 with phosphoric acid):methanol=4:6 The flow rate was 1.0mL/min. The wavelenth was 228nm. Results A satisfactory separation condition for the five related impurities, the impurities standard curve was good linear over the range of 0.2-3.5μg/mL. Conclusion The method is sensitive and accurate and it can be used to determine the relateted substances of bezafibrate acylate.

关 键 词：苯扎贝特酰化物 有关物质 系统适用性 

分 类 号：R927.2[医药卫生—药学] O657.72[理学—分析化学]