HPLC法测定异福酰胺胶囊及片的含量  

Determination of Rifampin,Isoniazid,and Pyrazinamide Capsules and Tablets by HPLC

作　　者：李冰 张亚杰 沈光 杨明 

机构地区：[1]辽宁省药品检验所,沈阳110023 [2]辽宁省血液中心,沈阳110044 [3]沈阳市第二人民医院,沈阳110002

出　　处：《中国药品标准》2005年第4期20-22,共3页Drug Standards of China

摘　　要：目的:建立异福酰胺胶囊及片的含量测定方法.方法:采用高效液相色谱法,选用Kromasil ODS C18色谱柱(4.6mm×20cm),流动相A:乙腈-0.05mol·L-1磷酸二氢铵溶液(3:97),流动相B:乙腈-0.05mol·L-1磷酸二氢铵溶液(55:45),梯度洗脱,0～4分钟,流动相A为100%,4～8分钟,流动相A由100%降到0%,8～15分钟,流动相B为100%;流速:1.0ml·min-1,检测波长:263nm.结果:利福平在20.3～101.5μg·ml-1,异烟肼在13.5～67.5μg·m-l,吡嗪酰胺在66.7～333.5μg·ml-1的浓度范围内,峰面积与浓度呈良好的线性关系,异福酰胺胶囊方法回收率分别为99.8%,99.1%,100.5%,RSD分别为0.44%,0.24%,0.40%;异福酰胺片方法回收率分别为100.1%,100.3%,100.4%,RSD分别为0.12%,0.53%,0.35%.结论:方法准确,灵敏,可靠,适用于异福酰胺胶囊及片的含量测定.Objective：To establish a method for determination of assay of Rifampin,Isoniazid,and Pyrazinamide Capsules and Tablets. Methods：An HPLC methou with graduate elution was applied ,equipped with Kromasil ODS C18 column （5μm, 4.6mm - 20cm）,using acetonitrile-0. 05mol/L ammonium dihydric phosphate （3 ： 97）as mobile phase A and acetonitrile-0.05mol/ L ammonium dihydric phosphate（55 ： 45）as mobile phase B. After isocratic elution with mobile phase A for 4 minutes,the proportion of mobile phase B increased linearly from 0% to 100% within 4 minutes and then hold on for 7 minutes. Flow rate was 1.0m! rain and detection wavelength 263nm. Results ： The linear ranges of Rifampin,Isoniazid ,and Pyrazinamide were respectively between 20. 1 - 100. 5μg/ml, 13.5 - 67.3μg/ml, 66.6 - 333.2μg/ml, and the recoveries of Rifampin, Isoniazid, and Pyrazinamide in Compound Capsule were 99.8% （RSD = 0.44 %）, 99.1 % （RSD = 0. 24% ）, 100.5% （RSD = 0. 400% ）, respectively; and the recoveries of Rifampin, Isoniazid, and Pyrazinamide in Compound Tablet were 100. 1% （RSD = 0.12%）, 100.3 % （RSD = 0. 53 %）, 100. 4% （RSD = 0. 35 % ）, respectively. Conclusion： The method is accu rate, sensitive, and reliable. It is practicable to apply the method for the assay of compound capsule and tablet.

关 键 词：高效液相色谱法 异福酰胺胶囊及片 梯度洗脱 异福酰胺胶囊 含量测定方法 HPLC法 磷酸二氢铵溶液 C18色谱柱 浓度范围 流动相 

分 类 号：R927.2[医药卫生—药学] R286.0