Optimization and validation of the pharmacopeial method for verifying the potential quality deviations of drug raw materials and compounded oral capsules of thyroid hormones
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Keywords

levotiroxina
liotironina
CLAE
cápsulas manipuladas
validação

How to Cite

1.
Markman BEO, Koschtschak MRW, Auricchio MT. Optimization and validation of the pharmacopeial method for verifying the potential quality deviations of drug raw materials and compounded oral capsules of thyroid hormones. Rev Inst Adolfo Lutz [Internet]. 2007 Aug. 1 [cited 2024 May 13];66(3):268-74. Available from: https://periodicos.saude.sp.gov.br/RIAL/article/view/32805

Abstract

Levothyroxine (T4) and Liothyronine (T3) have been used for hypothyroidism treatment, and these drugs control the speed of corporeal chemical functions. The present study aimed to optimize and validate the methodology described in United States Pharmacopeia 28 for T3 and T4 determination by means of HPLC-UV, in order to make it suitable for concomitant evaluation for assessing the quality of in compounded medicines. Optimization was achieved by using acidified water (phosphoric acid :acetonitrile) 52:50, in temperature at 27°C and flow of 1.6 mL min-1, and 250 x 4.6mm column constituted by nitriles group bounded to 3 to 10μm porous silica particles, and detection at 238nm. The number of theoretical plates was 8500 and the obtained resolution factor was 5.12, which showed the efficiency of chromatography conditions. When this methodology was applied for testing the content uniformity in T3 and T4 compounded capsules, quality deviations were detected. The super dosage of active drug substances was one of the found deviations. Inadequate and high doses of active drugs as hormones are harmful to the patients, leading to be hospitalized, and even to death owing to drug intoxication mainly with narrow therapeutics windows drugs. The data observed in the present study demonstrate the occurrence of technical limitations in compounding pharmacy, and also a lack of appropriate quality control.
https://doi.org/10.53393/rial.2007.66.32805
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