HPLC法测定来氟米特片中来氟米特的含量及含量均匀度  

Determination of Content and Content Uniformity of Dosage Units of Leflunomide in Leflunomide Tablets by HPLC

作　　者：杨红娟[1] 洪志玲[1] 曾民[1] 

机构地区：[1]厦门市药品检验所,福建厦门361012

出　　处：《中国药品标准》2010年第3期216-219,共4页Drug Standards of China

摘　　要：目的:建立来氟米特片中来氟米特的含量及其含量均匀度的HPLC测定法。方法:色谱柱:Waters SunfireTM C18(4.6mm×150mm,5μm);流动相:乙腈-水-三乙胺(35∶65∶5)(用磷酸调节pH至4.0);检测波长为254nm。结果:来氟米特在20.044～200.44mg·L-1范围内线性良好,相关系数r=0.99999(n=6);平均回收率为99.6%(n=9,RSD为0.3%)。结论:本法灵敏度高,重现性好,结果准确。Objective： To establish a method using HPLC for determination of the content and content uniformity of dosage units of Le- flunomidc in Leflunomide Tablets. Methods： A Waters SunfireTM Cls （4. 6 mm × 150 mm,5 μm, ） column was used with mobile phase of acetonitrile-water-triethylamine（35：65：5 ） ,adjusted to pH4. 0 with phosphoric acid, The detected wavelength was 254nm. Results： The calibration curve was linear in the concentration range of 20. 044 - 200. 44 mg. L - 1 , r = 0. 999 99 ; The average recovery was 99. 6% with a relative standard deviation of 0. 3%. Conclusion： The method is sensitive, precise and accurate.

关 键 词：来氟米特片 来氟米特 高效液相色谱法 

分 类 号：R684[医药卫生—骨科学]