高效液相色谱法测定瑞格列奈片中的有关物质  

Determination of the related substances in repaglinide tablets by HPLC

作　　者：林聪[1,2] 马红玲[1,2] 刘丹琦[1,2] 吕淑河[1,2] 李雪如 徐平声[1,4] 

机构地区：[1]中南大学湘雅医院药学部,长沙410008 [2]中南大学药学院,长沙410013 [3]株洲千金湘江药业有限公司,湖南株洲412200 [4]中南大学湘雅医院GCP办,长沙410008

出　　处：《中南药学》2013年第6期467-469,共3页Central South Pharmacy

摘　　要：目的采用高效液相色谱法对瑞格列奈片中有关物质进行测定。方法色谱柱为Diamonsil C18柱(250 mm×4.6 mm,5μm),流动相为磷酸二氢铵溶液(pH=2.5)-甲醇(30:70)混合溶液,流速为1.0 mL min-1,检测波长为210 nm。结果瑞格列奈与有关物质A(MPPBA)、B(ECPAA)均能有效分离,分离度均>1.5,检测限分别为2 ng、0.3 ng,精密度良好(RSD分别为0.35%、0.87%)。结论本方法快速、可靠、灵敏度高,适用于瑞格列奈制剂的有关物质控制。Objective To control the related substances in repaglinide tablets by HPLC.Methods The C18column（250 mm×4.6 mm,5 μm） was used.The mobile phase was the mixture of ammonium dihydrogen phosphate（pH = 2.5）-methanol（30 ：70） with flow rate at 1.0 mL min-1.The detection wavelength was 210 nm.Results Repaglinide and related substance A（MPPBA） and B（ECPAA） were well spearated.The detection limits were 2 ng and 0.3 ng,respectively,and the precision was good with RSD of 0.35% and 0.87%.Conclusion This method is easy to operate,reliable and highly sensitivite,which can be used to control the related substances in repaglinide tablets.

关 键 词：瑞格列奈 有关物质A 有关物质B 有关物质 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]