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提出了用高效液相色谱法监控左旋甲状腺素钠合成关键步骤偶联反应。色谱条件:YMC-Pack Pro C18反相色谱柱(4.6 mm×100 mm5,μm);甲醇-1‰磷酸水溶液为流动相,梯度洗脱;检测波长225 nm;流速1.0 mL/min。偶联反应液在0.05～0.25 mg/mL范围内线性关系良好(相关系数r=0.999 7);加标回收率为99.79%～100.05%;重复进样的平均RSD为1.35%。方法的准确度高,精密度好,实际应用效果好。
A key step coupling reaction for the monitoring of levothyroxine sodium synthesis using high performance liquid chromatography was proposed. Chromatographic conditions: YMC-Pack Pro C18 reversed-phase column (4.6 mm × 100 mm 5, μm); methanol-1 ‰ phosphoric acid aqueous solution as mobile phase with gradient elution; detection wavelength at 225 nm and flow rate of 1.0 mL / min. The linearity of the coupling reaction solution was good in the range of 0.05-0.25 mg / mL (r = 0.999 7). The spiked recoveries ranged from 99.79% to 100.05%. The average RSD of repeated injections was 1.35%. The method has high accuracy, good precision and good practical application effect.