Liothyronine Tablets
Action and use
Thyroid hormone replacement.
Definition
Liothyronine Tablets contain Liothyronine Sodium.
Content of liothyronine sodium, C15H11I3NNaO4
90.0 to 110.0% of the stated amount.
Identification
In the Assay, the retention time of the principal peak in the chromatogram obtained with solution (1) is the same as that of the peak in the chromatogram obtained with solution (2).
Test
Uniformity of content
Tablets containing less than 2 mg and/or less than 2% w/w of Liothyronine comply with the requirements stated under Tablets using the following method of analysis. Carry out the method for liquid chromatography, Appendix III D, using the following solutions in 0.05m sodium hydroxide.
5 volumes of orthophosphoric acid, 300 volumes of acetonitrile and 700 volumes of water.
Calculate the content of C15H11I3NNaO4 in each tablet using the declared content of C15H11I3NNaO4 in liothyronine sodium EPCRS.
Assay
Weigh and powder 20 tablets. Carry out the method for liquid chromatography, Appendix III D, using the following solutions in equal volumes of methanol and 0.1m sodium hydroxide (solvent A).
The chromatographic conditions described under Uniformity of content may be used.
The Assay is not valid unless the resolution factor between the two principal peaks in the chromatogram obtained with solution (3) is at least 4.0.
Calculate the content of C15H11I3NNaO4 in the tablets using peak areas and the declared content of C15H11I3NNaO4 in liothyronine sodium EPCRS.
Storage
Liothyronine Tablets should be protected from light.