HPLC法测定帕司烟肼中间氨基酚的含量  

Determination of content of m-aminophenol in pasiniazide by HPLC

作　　者：李思源[1] 何祖强[1] 

机构地区：[1]广州市药品检验所,广州510405

出　　处：《北方药学》2016年第4期7-8,共2页Journal of North Pharmacy

基　　金：磷酸伯安喹全球基金项目(全球基金国家药品标准提高课题);编号:GF2012-38

摘　　要：目的：建立帕司烟肼中间氨基酚检查方法,有效控制帕司烟肼产品中间氨基酚含量。方法：色谱柱：十八烷基硅烷键合硅胶柱,流动相：甲醇-10%四丁基氢氧化铵溶液-0.05mol/L磷酸氢二钠-0.05mol/L磷酸二氢钠（100∶21∶450∶450）,检测波长280nm。结果：方法在1.06~3.18μg/m L范围内线性关系好,相关系数r=0.9999（n=5）;加样回收率为99.7%,RSD=0.7%;仪器精密度高,多次进样RSD=0.7%（n=6）。结论：方法专属性强,分离度好,准确度高,能有效控制帕司烟肼中间氨基酚含量。Objective ：To establish the examination method of m-aminophenol in pasiniazide and to effectively control the content of maminophenol in pasiniazide products. Methods：The determination was performed on C18 column with methanol-10% of tetrabutylammonium hydroxide ammonium solution-0.05mol/L disodium hydrogen phosphate-0.05 mol/L sodium dihydrogen phosphate（100∶21∶450∶450 V/V/V/V）as mobile phase. The detection wavelength was set at 280 nm. Results：When the method was in the range of1.06~3.18μg/ml,the linear relation is good and the correlation coefficient was r=0.9999（n=5）; The sample recovery rate was 99.7%,RSD=0.7%; The instrument was with high precision and multiple injection RSD=0.7%（n=6）. Conclusion：The method is specific,with good separation and high accuracy. It can effectively control the content of m-aminophenol in pasiniazide.

关 键 词：HPLC 帕司烟肼 间氨基酚 

分 类 号：R927.2[医药卫生—药学]