应用反相高效液相法检测左旋甲状腺素钠片含量及溶出度的研究  

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

作　　者：孙传良 

机构地区：[1]哈药集团三精制药股份有限公司,黑龙江哈尔滨150050

出　　处：《黑龙江医药》2007年第3期191-193,共3页Heilongjiang Medicine journal

摘　　要：目的:建立左旋甲状腺素钠反相高效液相色谱测定方法,检测和比较自制与进口左旋甲状腺素钠片的含量和溶出度。方法:以甲醇-水-磷酸(600∶400∶1)作流动相,检测波长:225nm,流速1.0ml.min-1,测定2种片剂中左旋甲状腺素钠含量,依照现行中国药典溶出度测定法测定左旋甲状腺素钠片溶出度。结果:两种片剂含量占标示量的百分率分别为99.32%和99.63%。80分钟时,两种片剂溶出百分率均在75%以上。结论:本方法适用于左旋甲状腺素钠的含量测定,自制和进口左旋甲状腺素钠片剂的含量无差异,溶出度也无明显差异。Objective： To establish a methods for determination of content and dissolution of levothyroxine sodium tablet by RP - HPLC and determine the content and dissolution of self - made ande imported levothyroxine sodium. Methods： Tile concent of levothyroxine sodium was assayed with mobile phase consisting of methanol - water - phosphoric acid（ 600： 400： 1 ） at a flow rate of 1.0ml·min^-1 ,the detection wavelength was at 22 nm.. the study on dissolution was conducted according to the method Ⅱ of dissolution apparatus in Pharmacopoeia of the People＇s Republic of China（2005）. Results： The average content of two formulations was. 99. 32% and 99. 63%, respectively. There was a significant dissolution percentage between two levothroxine sodium tablets and all exceed 75% at 80 minutes. Conclusion：The methods is accurate and suitable for determination of levothyroxine sodium. There were no difference of the content and dissolution among the two levothroxine sodium tablets.

关 键 词：左旋甲状腺素钠 含量 溶出度 反相高效液相色谱法 

分 类 号：R927.2[医药卫生—药学]