高效液相色谱法测定左旋甲状腺素钠片的含量及溶出度  

Content and Dissolution Determination of Levothyroxine Sodium Tablets by HPLC

作　　者：常海莹 Chang Haiying(Xinxiang Institute of Food and Drug Control, Xinxiang, Henan, China 45300)

机构地区：[1]河南省新乡市食品药品检验所,河南新乡453000

出　　处：《中国药业》2017年第22期28-30,共3页China Pharmaceuticals

摘　　要：目的建立测定左旋甲状腺素钠片含量的高效液相色谱(HPLC)法,并比较2种片剂的含量及溶出度。方法用HPLC法测定2种钠片中的左旋甲状腺素钠含量,并按照《中国药典》的测定方法测定2种左旋甲状腺素钠片的溶出度。色谱柱为Hypersil BDS C18柱(150 mm×4.6 mm,5μm),柱温为25℃,流动相为甲醇-水-磷酸(600∶400∶1),检测波长为225 nm,流速为1.5 m L/min。结果 2种左旋甲状腺素钠片的含量占标示量的百分率分别为101.39%和99.32%;2种片剂溶出50%及63.2%所需的时间和m值比较,均有显著性差异(P<0.05)。结论 HPLC法是测定左旋甲状腺素钠片的有效方法,2种左旋甲状腺素钠片含量无明显差异,但溶出度差异明显。Objective To establish an HPLC method for content and dissolution determination of Levothyroxine Sodium Tablets. Methods The content of levothyroxine sodium in two kinds of sodium tablets was determined by HPLC, and the dissolution of two kinds of Levothyroxine Sodium Tablets was determined according to the determination method of Chinese Pharmacopoeia. The chromatographic column was Hypersil BDS Cis column（150 mm×4. 6 mm,5 μm） , the column temperature was 25℃,the mobile phase consisted of methanol - water - phospho-ric acid （600 ： 400 ： 1）,the detection wavelength was 225 nm,and the flow rate was 1. 5 mL/min. Results The percentages of the contents of the two kinds of Levothyroxine Sodium Tablets were 101. 39% and 99. 32% ,respectively. The time and m value of 50% and 63. 2 % dis-solution of two tablets showed significant difference （ P 〈 0. 05）. Conclusion HPLC is the effective method for the determination of Levothy- roxine Sodium Tablets. There is no significant difference in the content of two kinds of Levothyroxine Sodium Tablets, but the dissolution rate is obviously different.

关 键 词：左旋甲状腺素钠 高效液相色谱法 含量 溶出度 

分 类 号：R927.2[医药卫生—药学] R977.14