高效液相色谱法测定来氟米特片的溶出度  

Determination of dissolution in leflunomide tablets by HPLC

作　　者：洪志玲[1] 杨红娟[1] 曾明[1] 

机构地区：[1]福建厦门市药品检验所,厦门361012

出　　处：《海峡药学》2012年第10期63-65,共3页Strait Pharmaceutical Journal

摘　　要：目的建立高效液相色谱法测定来氟米特片溶出度的方法。方法采用《中国药典》2010年版溶出度测定法第二法,以水1000mL为溶出介质,转速100r·min-1,溶出时间为30min,以乙腈-水-三乙胺(35∶65∶0.5)(用磷酸调节pH至4.0)为流动相,检测波长为262nm,采用HPLC法测定溶出量。结果在2.0μg·mL-1～20μg·mL-1范围内线性良好,相关系数r=0.99999(n=6);平均回收率为100.9%(n=9,RSD为1.0%)。结论本法简便、准确、重现性好,符合溶出度方法的建立原则。OBJECTIVE To establish a method for the dissolution test of leflunomide tablets by HPLC.METHODS Dissolution method Ⅱ in the Chp 2010 edition was used,1000mL of water was taken as the dissolution medium and rotation speed was 100r·min-1.After 30min analyzed by HPLC and the mobile phase was acetonitrile-water-triethylamine（35∶65∶0.5）,the UV detection wavelength was at the 262nm.RESULTS Within the range of 1.0μg·mL-1～16.6μg·mL-1 were in linear correlation（r=0.9999）.The average recovery was 100.9% and RSD was 1.0%（n=9）.CONCLUSION The method is simple and reliable,and it was consistent with the principle of the determination of dissolution.

关 键 词：来氟米特片 溶出度 水 高效液相色谱法 

分 类 号：R927.2[医药卫生—药学]