高效液相色谱法测定匹多莫德片的溶出度  

HPLC Determination of the Dissolution of Pidotimod Tablets

作　　者：张翼[1] 张宝顺[1] 杨雅莉[1] 王德珍[1] 李学刚[1] 袁吕江[1] 

机构地区：[1]西南大学药学院,重庆400716

出　　处：《西南大学学报（自然科学版）》2013年第7期175-180,共6页Journal of Southwest University(Natural Science Edition)

基　　金：国家科技部十二五科技支撑项目(2011BAI13B02-1);中央高校基本科研基金资助项目(XDJK2009C087);西南大学博士科研启动基金资助项目(SWU111072)

摘　　要：建立了匹多莫德片溶出度测定的高效液相色谱法.采用Ecosil C18色谱柱(250mm×4.6mm,5μm),流动相为0.01mol/L磷酸二氢钠溶液-甲醇-异丙醇(97∶2∶1),流速为1.0 mL/min,检测波长为210nm,柱温为25℃,外标法定量.照《中华人民共和国药典》(2010年版)二部附录溶出度测定方法之桨法,采用RCZ-6B2药物溶出度仪,以水为溶出介质测定溶出度.结果表明此方法在270～630μg/mL范围内线性良好,r=0.999 9(n=5),检测限为3.125ng/mL,中间精密度相对标准偏差值分别为0.35%,0.56%.To establish an HPLC（High Performance Liquid Chromatography） method for the determination of dissolution profiles of pidotimod tablets,HPLC analysis was carried out by using the Ecosil C18（250 mm×4.6 mm,5 μm） column,with a mixture of 0.01 mol/L sodium dihydrogen phosphate,methonal and isopropanol（97∶2∶1） as the mobile phase,a flow rate of 1.0 mL/min,a detection wavelength of 210 nm and a column temperature of 25 ℃.The external standard was used for quantification.Determination of dissolution was based on the stirring paddle method recommended in the Chinese Pharmacopoeia（2010）.RCZ-6B2 drug dissolution apparatus was used and water was adopted as the dissolution medium.The calibration curves were linear over the concentration range of 270-630 μg/mL,r=0.999 9（n=5）.The limit of detection for the assay was 3.125 ng/mL.An intermediate precision test was performed by two persons,each taking 6 sample tablets from the same batch and making 6 determinations.The RSD（relative standard deviation） of the intermediate precision they obtained was 0.35% and 0.56%,respectively,suggesting that the determination method in this study had satisfactory intermediate precision.

关 键 词：高效液相色谱法 匹多莫德片 溶出度 

分 类 号：R944.4[医药卫生—药剂学]