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EFFECT OF EXCIPIENTS ON THE STABILITY OF LEVOTHYROXINE SODIUM TABLETS
Author(s) -
Gupta V. Das,
Odom C.,
Bethea C.,
Plattenburg J.
Publication year - 1990
Publication title -
journal of clinical pharmacy and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.622
H-Index - 73
eISSN - 1365-2710
pISSN - 0269-4727
DOI - 10.1111/j.1365-2710.1990.tb00393.x
Subject(s) - excipient , levothyroxine , chromatography , high performance liquid chromatography , chemistry , food and drug administration , medicine , pharmacology , biochemistry , hormone
Summary 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.