High-Performance Liquid Chromatographic Assay for Sodium Levothyroxine in Tablet Formulations: Content Uniformity Applications

作者: R.L. Garnick , G.F. Burt , D.A. Long , J.W. Bastian , J.P. Aldred

DOI: 10.1002/JPS.2600730120

关键词:

摘要: Sodium levothyroxine was quantitated in 25-300 micrograms/tablet formulations. The procedure consisted of pulverization a suitable sample, extraction into acetonitrile-water (40:60, v/v) containing 0.05% o-phosphoric acid, and injection onto bonded-phase cyanopropyl column; the effluent monitored by UV detection at 225 nm. Spiked placebo recovery studies demonstrated linearity method over range 80-120% label claim. Stability indicated that no degradation products or excipients interfered with quantitation intact drug. Data demonstrating accuracy precision this assay are presented, applied to measurement single-tablet content uniformity.

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