Enantiomeric separation and optical purity determination of thyroxine enantiomers in bulk and pharmaceutical formulations

Autor: Hassan Y. Aboul-Enein, Laila I. Abou-Basha
Rok vydání: 1995
Předmět:
Zdroj: Pharmaceutica Acta Helvetiae. 70:237-240
ISSN: 0031-6865
DOI: 10.1016/0031-6865(95)00024-4
Popis: A base-line separation of racemic thyroxine is achieved by an HPLC method using an ovomucoid protein column. The mobile phase consists of 20 mM KH2PO4 (pH 6.7)/acetonitrile/methanol (100:15:5), and the effluent is monitored by UV detection at 220 nm. A standard linear calibration curve is constructed over the range of 0.25–10 nmol l -thyroxine sodium (L-T4) for the determination of optical purity of L-T4 in pharmaceutical formulations. The method is specific and sufficiently sensitive with a lower detection limit of 0.1 nmol (for both L-T4 and D-T4). Data demonstrating recovery and precision of the assay is presented, and the method is applied to determine l -thyroxine sodium in injectable formulations.
Databáze: OpenAIRE