摘要
目的建立GC法测定盐酸金刚乙胺片溶出度的方法。方法照《中国药典》2010年版二部附录溶出度测定法中第二法,以蒸馏水500mL为溶剂,转速50r.min-1,30min时采样。采样后以GC法测定,经氢氧化钠碱化处理,正己烷提取,以金刚烷为内标物质,采用分流进样法,以RESTEK Rtx-5毛细管色谱柱(30 m×0.32 mm×0.25μm)为分析柱进行分离测定。结果盐酸金刚乙胺在3.98～79.60μg范围内线性关系良好(r=0.9999);平均回收率为99.82%,RSD=0.56%(n=9)。结论该方法简便、快速、准确,能有效控制盐酸金刚乙胺片的质量。
Objective To establish a GC method for detecting dissolution of rimantadine hydrochloride tablets. Methods According to AppendixX C Ⅱ of ChP （2010 edition） Vol. Ⅱ , sampling was performed under conditions of dissolution medium 500 mL of water and rotating speed 50 rpm at 30min. Then the dissolution solution of the tablets was taken and analyzed by the GC method. The solution was alkalized with sodium hydroxide, and diluted by n-hexane, and then separated by Rtx-5 capillary column （30 m×0.32 mm× 0.25 μm） with split injection, using adamantine as the internal reference. Results A good linearity of rimantadine hydrochloride was achieved in the range of 3.98-79.60 μg, with average recovery of 99.82%, RSD=0.56% （n=9）. Conclusion The method is accurate, simple, rapid method with good reproducibility for the quality control of rimantadine hydrochloride tablets.
出处
《中国药事》
CAS
2013年第1期45-47,54,共4页
Chinese Pharmaceutical Affairs
关键词
盐酸金刚乙胺
盐酸金刚乙胺片
溶出度
毛细管气相色谱法
rimantadine hydrochloride
rimantadine hydrochloride tablets
dissolution~ capillarygas chromatography
