EFFECT OF EXCIPIENTS ON THE STABILITY OF LEVOTHYROXINE SODIUM TABLETS

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Abstract
Levothyroxine sodium tablets from two different manufacturers were analysed using the USP-NF method of analysis, a stability-indicating high pressure liquid chromatographic (HPLC) procedure. The results indicate that one particular manufacturer's 0.2-mg pink tablets contain some excipient(s) which act as a catalyst to hasten decomposition after extraction of levothyroxine for analysis. The same tablets from a different batch showed an additional long peak in the chromatogram, which indicated that the excipient(s) may have been changed. The same manufacturer has also used three different types of bottles/lids for the same product during the last year. Good manufacturing practice requires that new compatibilities/ stability studies be conducted to assure the quality of the product. Ongoing stability studies are required by the Food and Drugs Administration (FDA). The use-life of 0–2-mg pink tablets of this manufacturer may be short.