高效液相色谱法测定爱普列特片的含量和溶出度  

HPLC determination of the content and dissolution of epristeride tablets

作　　者：颜冬梅[1] 屠凌岚[1] 宋忠英[1] 彭小英[1] 李文钧[1] 

机构地区：[1]浙江省医学科学院,杭州310013

出　　处：《药物分析杂志》2007年第8期1264-1266,共3页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立测定爱普列特片的含量和溶出度的高效液相色谱法。方法:色谱柱为北京迪马 Diamonsil^(TM)C_(18)柱(250 mm×4.6 mm,5μm),流动相为甲醇-异丙醇-水(82:3:15),检测波长为266 nm。按中国药典转篮法,采用天津大学无线电厂ZRS-8G 智能溶出试验仪,以0.001 mol·L^(-1)氢氧化钠溶液为溶出介质测定溶出度。结果:在0.5～20 mg·L^(-1)浓度范围,爱普列特的峰面积与浓度呈良好线性关系(r=0.9998),加样回收率为98.3%,相对标准偏差为1.2%(n=5)。5 min 溶出为42%～51%,10 min 溶出超过65%,3批片剂的50%溶出时间 T_(50)为3.4～6.1 min。结论:方法简便可靠,能够满足爱普列特片含量和溶出度测定的要求。Objective ： To develop an RP - HPLC for determination of epristeride tablets and its dissolution. Method ： The chromatographic conditions were ： Diamonsil^TM C18 column （250 mm×4.6 ram,5 μm） ; methanol - isopropyl alcohol -water （82： 3： 15） as mobile phase at detection wavelength of 266 nm. The dissolution study was analyzed by ZRS -8G dissolution analyzer, following the standard ChP procedure. Results：The calibration curves was linear over the concentration range of 0. 5 - 20 mg· L^- 1 and the average recoveries （ n = 5 ） of epristeride were 98.3% ,RSD = 1.2% （n =5）. The dissolutions were 42% - 51% at 5 min,the haft times of dissolution T50 were 3. 4 - 6. 1 min. Conclution： The method is simple, accurate and suitable for determination of epristeride tablets and its dissolution.

关 键 词：爱普列特片 溶出度 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]