高效液相色谱法测定德拉昔布咀嚼片的体外溶出度  

The Dissolution Rate of Deracoxib Chewable Tablets in vitro Determinated by HPLC

作　　者：郭桂芳[1] 于泓潇 李思鸿 张艺馨 程平[2] 张秀英[2] GUO Gui-fang;YU Hong-xiao;LI Si-hong;ZHANG Yi-xin;CHENG Ping;ZHANG Xiu-ying(China Institute of Veterinary Drug Control, Beijing 100081, China;College of Veterinary Medicine, Northeast Agricultural University, Harbin 150030, China)

机构地区：[1]中国兽医药品监察所,北京100081 [2]东北农业大学动物医学学院,哈尔滨150030

出　　处：《中国兽药杂志》2021年第1期35-40,共6页Chinese Journal of Veterinary Drug

摘　　要：建立了德拉昔布咀嚼片溶出度测定的高效液相色谱法,并对德拉昔布咀嚼片和Deramaxx咀嚼片的溶出度进行比较。方法为浆法,转速为50 r/min,0.8%十二烷基硫酸钠为溶出介质,于5、10、15、20、30、40、50 min分别采样;采用Waters XSelect H88 C18(4.6 mm×250 mm,5μm)色谱柱,磷酸盐缓冲液(pH4.5)-乙腈(52∶48,V/V)为流动相,检测波长252 nm;柱温30℃;外标法定量。结果表明,德拉昔布在5~25μg/mL浓度范围内线性良好(r^(2)=0.9992),检测限与定量限分别为0.81μg/mL、2.57μg/mL;平均回收率为101.8%±0.91%;德拉昔布咀嚼片与Deramaxx溶出度在30 min内分别为87.78%±1.91%和88.76%±2.05%,符合规定。试验所建立的方法简便、准确、专属性强,可用于德拉昔布咀嚼片的溶出度测定。A method for the determination of the dissolution of Deracoxib chewable tablets was developed by high performance liquid chromatography,and the dissolution of Deracoxib chewable tablets and Deramaxx chewable tablets were compared.The paddle method was used for 50 r/min,and the dissolution medium was 0.8%sodium dodecyl sulfate,sample solution was collected at 5,10,15,20,30,40 and 50 min respectively.It was tested with Waters XSelect H88 C18(4.6 mm×250 mm,5μm)chromatographic column.The mobile phase was phosphate buffer(pH4.5)-acetonitrile(52∶48,V/V),and detection wavelength was 252 nm,column temperature was 30℃.External standard method was adopted for quantitative analysis.The results demonstrated that Deracoxib showed a good linear response in the range of 5~25μg/mL(r^(2)=0.9992).The detection limit and quantitative limit were 0.81μg/mL and 2.57μg/mL respectively.The average recovery of the method was 101.8%±0.91%.The dissolution of Deracoxib chewable tablets 87.78%±1.91%and Deramaxx 88.76%±2.05%were both above 85%in accordance with relevant regulations.The HPLC method was simple,accurate and specific,which could be used for the determination of the dissolution of Deracoxib chewable tablets.

关 键 词：德拉昔布咀嚼片 HPLC法 溶出度 

分 类 号：S859.79[农业科学—临床兽医学]