The medication I'm working on is levothyroxine sodium tablets and my goal is to separate the API from the rest of the tablet but the solvent that could dissolve pure levothyroxine doesn't work on the tablets as it has no signals when ran on MS. Anyone have any idea?
The inactive ingredients are
Butylated Hydroxyanisole Crospovidone Silicon Dioxide (Colloidal) D&C Red No. 27 D&C Red No. 30 Sodium Lauryl Sulfate Microcrystalline Cellulose Sucrose Magnesium Stearate Mannitol Povidone
Levothyroxine is very slightly soluble in water, slightly soluble in ethanol (96 per cent). It dissolves in dilute solutions of alkali hydroxides. Lower the pH and add salt in the solution together with an antisolvent. The API will migrate in the organic layer. Separate the phases, add hydroxide in the organic containing your API to precipitate the API salt.
First you need to separate all the ingredients of the tablet, which do not dissolve in aqueous media. Disperse the tablet in a dilute solutions of any alkali hydroxide. Pass the dispersion through a 1 mcm filter. After that change pH to 5-6 to precipitate the API.
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