RP-HPLC法检测左旋甲状腺素钠片剂含量及溶出度  

Determination of Content and Dissolution of Levothyroxine Sodium Tablet by RP-HPLC

作　　者：伍杰雄[1] 任斌[1] 唐蕾[1] 

机构地区：[1]中山医科大学附属第一医院药学部,广东广州510080

出　　处：《中山医科大学学报》2001年第3期238-240,共3页Academic Journal of Sun Yat-sen University of Medical Sciences

摘　　要：【目的】建立左旋甲状腺素钠反相高效液相色谱 (RP HPLC)测定法 ,检测和比较 2种进口的左旋甲状腺素钠片剂的含量和溶出度。【方法】用RP HPLC法测定 2种片剂中左旋甲状腺素钠含量 ,依照美国药典第 2 3版溶出度测定Ⅱ法测定左旋甲状腺素钠片剂溶出度。色谱条件 :HypersilBDSC18柱 ;流动相 :0 85 (mL/ 10 0mL)磷酸溶液 甲醇 (4 0∶6 0 ) ;检测波长 :2 2 5nm ;流速 :1 5mL/min。【结果】 2种片剂含量占标示量百分率分别为 10 7 74%和 99 72 %。两种片剂溶出 5 0 %和6 3 2 %所需的时间及m值均有极显著性差异 (P <0 0 1)。【结论】两种进口左旋甲状腺素钠片剂的含量无差异 。To determine the content and dissolution of two imported levothyroxine sodium tablets. The content of levothyroxine sodium was assayed on a Hypersil BDS C18 column with a mobile phase consisting of methanol 0 85% phosphoric acid (60∶40) at a flow rate of 1 5 mL/min and detected at 225 nm. The study on dissolution was conducted according to the method Ⅱ of dissolution apparatus in USP(23). The average content of two formulations was 107 74% and 99 72%, respectively. The value of T 50 , T d and m of two tablets differed significantly (P<0 01). [Conclusion] There was a significant dissolution difference between two levothyroxine sodium tablets.

关 键 词：左旋甲状腺素钠 片剂 含量测定 溶出度 RP-HPLC 

分 类 号：R977.14[医药卫生—药品] R927.2[医药卫生—药学]