高效液相色谱法测定复合制剂中异烟肼和利福平含量

Determination of isoniazid and rifampin by HPLC in compound preparation

抗结核药物的复合制剂有其突出的优点。其含量的测定繁杂费时，需要逐个药物分别测定。本文报告一种可以同时测定异烟肼和利福平两种药物的高效液相色谱法。本法用Ｓｐｈｅｒｉｓｏｒｂ Ｃ８（４．６×２５０ｍｍ，５μｍ，ＩＤ）色谱柱，以甲醇：０．０５ＭＮａＡｃ／ＨＡＣ缓冲液（ｐＨ６．９０）＝６５：３５（Ｖ：Ｖ）为流动相，流速１．０ｍｌ／ｍｉｎ，紫外检测器检测（＝２５４ｎｍ）。结果：异烟肼和利福平的保留时间分别为３．０１１ｍｉｎ和６．７９ｍｉｎ，在１．０～２０．０μｇ／ｍｌ浓度范围内线性关系分别为：Ｙ＝２０１７．４０Ｘ－３３９．９５，ｒ＝０．９９９７；Ｙ＝２１００．７０Ｘ＋１２５．７６，ｒ＝０．９９９５，日内变异分别为 １．８３％、２．０８％；日间差异分别为 １．８９％、２．１７％。回收率分别为 ９９．７２％、９８．２７％。本法快速，可同时测定两种药物。

A high performance liquid chromatograph method for the quantitative analysis of isoniazid and rifampin in compound preparation was described. High - Performance liquid charomatograph Model LC-10A(SHIMADZU,Japan)with a 254nm wavelengh uv - detector and Spherisorb C8 column(5um, 250mm×4. 6mm)was used. The mobile phase of methanol and 0. 05M NaAc/HAC buffer(65: 35, v/v, pH6. 90)was pumped at 1. 0ml/min through the column,The detector was operated at 0. 016 AUFS. The retention the for isoniazid and rifampin was 3. 011, 6. 799 min, respectively. Standard curve was linear in the concentration range of 1. 0 to 20.0μg/ml for hath isoniazid and rifampin. The recovery rate was 95. 60 % -101 .40%.Wilson - day RSD was less than 3. 17%, inter - day RSD was less than 3. 07% for both isoniazid and rifampin.The results shed this method for the simultaneous measurement of both isoniazhid and rifampin in compound prepa- ration was sensitive and specific.