Garnick R L, Burt G F, Long D A, Bastian J W, Aldred J P
J Pharm Sci. 1984 Jan;73(1):75-7. doi: 10.1002/jps.2600730120.
Sodium levothyroxine was quantitated in 25-300 micrograms/tablet formulations. The procedure consisted of pulverization of a suitable sample, extraction into acetonitrile-water (40:60, v/v) containing 0.05% o-phosphoric acid, and injection onto a bonded-phase cyanopropyl column; the effluent was monitored by UV detection at 225 nm. Spiked placebo recovery studies demonstrated the linearity of the method over the range of 80-120% of the label claim. Stability studies indicated that no degradation products or excipients interfered with the quantitation of the intact drug. Data demonstrating the accuracy and precision of this assay are presented, and the method was applied to the measurement of single-tablet content uniformity.
对左甲状腺素钠25 - 300微克/片剂型进行了定量分析。该方法包括将合适的样品粉碎，用含0.05%正磷酸的乙腈 - 水（40:60，v/v）进行萃取，然后注入键合相氰丙基柱；流出物通过在225nm处的紫外检测进行监测。加标安慰剂回收率研究表明该方法在标签声称量的80 - 120%范围内呈线性。稳定性研究表明没有降解产物或辅料干扰完整药物的定量分析。给出了证明该分析方法准确性和精密度的数据，并且该方法被应用于单片片剂含量均匀度的测定。
