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A Review of Analytical Methods for the Determination of Tibolone: Pharmacokinetic and Pharmaceutical Formulations Analysis and Application in Doping Control

Author(s):

Marilene Lopes Ângelo, Fernanda de Lima Moreira*, Ana Laura Araújo Santos, Hérida Regina Nunes Salgado and Magali Benjamim de Araújo  

Abstract:


Background: Tibolone is a synthetic steroid commercialized by Organon under the brand name Livial (Org OD14), which is used in hormone therapy for menopause management and treatment of postmenopausal osteoporosis. Tibolone is defined as a selective tissue estrogenic activity regulator (STEAR) demonstrating tissue-specific effects on several organs such as brain, breast, urogenital tract, endometrium, bone and cardiovascular system.

Aims: This work aims to (1) present an overview of important published literature about existing methods for the analysis of the tibolone and/or its metabolites in pharmaceutical formulations and biological fluids and (2) to conduct a critical comparison of the analytical methods used in doping control, pharmacokinetic and pharmaceutical formulations analysis of tibolone and its metabolites.

Results and conclusions: The major analytical method described for analysis of tibolone in pharmaceutical formulations is High pressure liquid chromatography (HPLC) coupled to ultraviolet (UV) detection, while Liquid chromatography (LC) or Gas chromatography (GC) used in combination with mass spectrometry (MS) or tandem mass spectrometry (MS/MS) is employed in analysis of tibolone and/or its metabolites in biological fluids.

Keywords:

Tibolone, HPLC, LC-MS/MS, UPLC-MS/MS, GC-MS, Analytical methods

Affiliation:

Faculty of Pharmaceutical Sciences, Federal University of Alfenas, 700, Rua Gabriel Monteiro da Silva, 37130-000, Alfenas, MG, School of Pharmaceutical Sciences of Ribeirão Preto, University of São Paulo, 14040-903, Ribeirão Preto, SP, School of Biological Sciences - Bangor University, Deiniol Road, LL57 2UW, Bangor, Faculty of Pharmaceutical Sciences, UNESP, Campus Araraquara, Rodovia Araraquara Jaú, km 01, 14800-903, Araraquara, SP, Faculty of Pharmaceutical Sciences, Federal University of Alfenas, 700, Rua Gabriel Monteiro da Silva, 37130-000, Alfenas, MG



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