固相萃取-高效液相色谱法测定人血清中左甲状腺素钠

Determination of levothyroxine sodium in human serum by high performance liquid chromatography combined with solid-phase extraction

研究了固相萃取一高效液相色谱法测定人血清中左甲状腺素钠的方法。血清样品经MCX固相萃取小柱提取后进样测定；色谱条件为：色谱柱ODS柱（150mm×4．6mm i．d．，4．6μm），流动相为甲醇：H3P04溶液（60：40，y：V，pH3．00）；流速为1．0mL／min，检测波长225nm,柱温30℃，进样量20μL。在0．005—10．0μg／mL浓度范围内，关系线性关系良好；检出限为0．002μg／mL；RSD〈6．4％，回收率在96．6％～104．4％之间。方法适用于左甲状腺素钠的人体药代动力学及生物利用度研究。

A method for the determination of levothyroxine sodium in human serum by high performance liquid chromatography combined with solid - phase extraction was reported in this work. Serum samples were extracted with MCX solid - phase extraction cartridges. The chromatographic separation was performed on a ODS column （ 150 mm ×4.6mm i.d.,4.6μm）. The mobile phase consisted of methanol - pH 3.00 phosphate aqueous solution （60：40, V/V） , with a flow rate of 1.0 mL/min. The detection wavelength was 225 nm. The column temperature was 30 ℃ and the injection volume was 20 μL. Results showed that, the linear range was 0.005 10.0 μg/mL with a detection limit of 0. 002 μg/mL. RSD was less than 6.4% and the recoveries were in the range of 96.6% - 104.4%, demonstrating a good precision and accuracy. This method is specific, accurate, sensitive, simple, and suitable for the studies on pharmacokinetics and bioavailability of levothyroxine sodium in human body.