HPLC法测定乙胺吡嗪利福异烟片Ⅱ中盐酸乙胺丁醇的含量  

Determination of Ethambutol Hydrochloride in Ethambutol Hydrochloride-Pyrazinamide-Rifampicin-Isoniazid TabletsⅡ

作　　者：庞大海[1] 李妍妍[1] 韩文忠[1] 王卓[1] 

机构地区：[1]沈阳红旗制药有限公司,沈阳市110179

出　　处：《中国药房》2009年第10期779-781,共3页China Pharmacy

基　　金：国家火炬计划项目(2006GH020162)

摘　　要：目的:建立以高效液相色谱法测定乙胺吡嗪利福异烟片Ⅱ中盐酸乙胺丁醇含量的方法。方法:色谱柱为Alltima CN,流动相为乙腈-三乙胺的水溶液(50:50),稀释剂为Na_2HPO_4溶液,检测波长为200 nm,流速为1.0 mL·min^(-1),柱温为室温,进样量为20μL。结果:盐酸乙胺丁醇检测浓度的线性范围为100.2～601.2μg·mL^(-1)(r=0.999 98);平均回收率为99.8%,RSD= 0.374%。结论:本方法操作简单、结果准确、重现性好,可用于该制剂的质量控制。OBJECTIVE： To establish an HPLC method for the determination of the content of ethambutol hydrochloride in ethambutol hydrochloride pyrazinamide rifampicin- isoniazid tablets Ⅱ . METHODS： The sample was separated on Alltima CN column. The mobile phase was acetonitrile - triethylamine （50 ： 50） water solution at a flow rate of 1.0 mL · min^-1. The diluent agent was Na2HPO4 solution. The detective wavelength was set at 200 nm; the column temperature was maintained at room temperature and the sample size was 20 μL. RESULTS： The linear range of ethambutol hydrochloride was 100.2-601.2μg · mL ^-1 （r = 0.999 98） and its average recovery was 99.8% （RSD = 0.374%） . CONCLUSIONS： The method is simple, accurate and reproducible, and it can be used for the content determination of ethambutol hydrochloride in this tablet.

关 键 词：高效液相色谱法 盐酸乙胺丁醇 乙胺吡嗪利福异烟片Ⅱ 含量测定 

分 类 号：R927.2[医药卫生—药学] R978.3