HPLC法测定异福胶囊中异烟肼和利福平的含量

目的：建立异福胶囊中同时测定异烟肼和利福平的含量的方法。方法采用HPLC梯度洗脱法，色谱柱为十八烷基硅烷键合硅胶为填充柱（Agilent ZORBAX Eclipse XDB－C18，4．6mm ×250mm，5μm），流动相分别为流动相A：甲醇－0．015mol? L －1磷酸二氢钠溶液（用磷酸调节pH值为6．5）（5∶95），流动相B：甲醇－0．015mol? L－1磷酸二氢钠溶液（用磷酸调节pH值为6．5）（62∶38）；流速：1．3mL? min －1，检测波长：262nm。结果以峰面积（y）对进样浓度（x）线性回归，异烟肼回归方程：y＝29773x－7020．2，r＝0．9998，线性范围为11．48～183．6μg? mL －1；利福平回归方程：y＝35061x－67601，r＝0．9997，线性范围为13．78～275．6μg? mL －1，峰面积与浓度呈良好的线性关系。异烟肼和利福平加样回收率分别为：分别为100．1％和99．9％（n＝9），RSD分别为O．23％和0．26％。结论本方法操作简便、准确、重现性好，可用于同时测定异福胶囊中异烟肼和利福平的含量。

Determination of Isoniazid and Rifampicin in Yifu CapsuIes by HPLC

OBJECTIVE To establish a method for simultaneous determination of isoniazid and rifampicin in Yifu capsules.METHODS HPLC gradient elution column was octadecylsilane bonded silica as Packed column (Agilent ZORBAX Eclipse XDB-C18,4.6mm ×250mm,5μm),the mobile phase were as follows:the mobile phase A:methanol-0.015 mol? L-1 sodium dihydrogen phosphate solution ( 5∶95 ) , mobile phase B:methanol-0.015 mol?L-1 phosphate sodium dihydrogenphosphate solution ( 62∶38 );flow rate was 1.3 mL? min -1 , detection wavelength was 262 nm.RESULTS The linear regression equation for isoniazid was y =29773 x-7020.2 ,r=0.9998 ,the line-ar range was 11.48~183.6μg? mL-1;The linear regression equation for rifampicin was y =35061 x-67601 , r=0.9997 ,and the linear range was 13.78~275.6μg? mL-1 ,peak area and concentration showed a good linear rela-tionship.The average recovery were 100.1%and 99.9%for isonizid and rifampicin ,RSD were 0.23%and 0.26%. CONCLUSION The method is simple ,accurate ,reproducible ,and can be used for simultaneous determination of i-soniazid and rifampicin in Yifu capsules .