| RP-HPLC法检测左旋甲状腺素钠片剂含量及溶出度 |
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| 引用本文： | 伍杰雄,任斌,唐蕾.RP-HPLC法检测左旋甲状腺素钠片剂含量及溶出度[J].中山大学学报(医学科学版),2001,22(3):238-240. |
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| 作者姓名： | 伍杰雄 任斌 唐蕾 |
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| 作者单位： | 中山医科大学附属第一医院药学部, |
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| 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23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/100mL)磷酸溶液-甲醇(40∶60)；检测波长225nm；流速1.5mL/min。【结果】2种片剂含量占标示量百分率分别为107.74%和99.72%。两种片剂溶出50%和63.2%所需的时间及m值均有极显著性差异(P<0.01)。【结论】两种进口左旋甲状腺素钠片剂的含量无差异，但溶出度存在显著性差异。
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| 关 键 词： | 左甲状腺素/分析 高压液相色谱法 |
| 文章编号： | 1000-257X(2001)03-0238-03 |
| 修稿时间： | 2000年3月21日 |
Determination of Content and Dissolution of Levothyroxine Sodium Tablet by RP-HPLC |
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| WU Jie-xiong,REN Bin,TANG Lei.Determination of Content and Dissolution of Levothyroxine Sodium Tablet by RP-HPLC[J].Journal of Sun Yatsen University(Medical Sciences),2001,22(3):238-240. |
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| Authors: | WU Jie-xiong REN Bin TANG Lei |
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| Abstract: | 【Objective】To determine the content and dissolution of two imported levothyroxine sodium tablets.【Method】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).【Results】The average content of two formulations was 107.74% and 99.72%,respectively.The value of T50,Td and m of two tablets differed significantly (P<0.01).【Conclusion】There was a significant dissolution difference between two levothyroxine sodium tablets. |
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| Keywords: | levothyroxine sodium/analysis RP-HPLC |
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