一种抗偏头痛复方制剂体外溶出度的比较研究(英文)

作     者：HIREMATH Vijay Basayya KALIAPERUMAL Krishna BHOJRAJ Suresh NANJAN Mulla Joghee HIREMATH Vijay Basayya;KALIAPERUMAL Krishna;BHOJRAJ Suresh;NANJAN Mulla Joghee

作者机构：TIFAC CORE HDJSS College of PharmacyRocklands JSS UniversityBanim antap 

出 版 物：《色谱》 (Chinese Journal of Chromatography)

年 卷 期：2010年第28卷第1期

页      面：93-99页

核心收录：

学科分类：081704[工学-应用化学] 07[理学] 08[工学] 0817[工学-化学工程与技术] 070302[理学-分析化学] 0703[理学-化学] 

主　　题：甲氧萘丙酸 萘普生 钠 琥珀酸盐 分解方法 

摘      要：A novel in vitro dissolution profile was developed for formulated drug in combinational form containing naproxen sodium ( NAP) and sumatriptan succinate ( SUMA). This study was performed to understand the dissolution of the drug in the physiological temperature and pH. Dissolution testing was performed using USP 29 type II testing apparatus rotating at 50 r /min,in 900 mL deaerated buffer (pH 1. 2,4. 5 and 6. 8) which was maintained at ( 37 ± 0. 5) ℃. Quantification was performed using a developed and validated high performance liquid chromatographic (HPLC) method. Aceclofenac (ACE) was used as internal standard. SUMA,ACE and NAP w ere eluted at 4. 8,5. 7 and 7. 9 min,respectively. As expected for enteric coated immediate release (IR) tablets,the dissolution of NAP and SUMA was rapid and essentially complete within 2 h using phosphate buffer ( pH 6. 8). The comparison of the dissolution profiles was realized by model independent approach using a difference factor ( f1) ,similarity factor (f2) and dissolution efficiency ( DE). Statistical results show ed the pro-files were similar to the reference and the test products. Hence,this method demonstrated to be adequate for in vitro studies of NAP and SUMA in the combinational dosage form,since there is no official monograph,col-laborating to the official codes.