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A Review of Analytical Methods for the Determination of Tibolone: Pharmacokinetics and Pharmaceutical Formulations Analysis and Application in Doping Control
Current Pharmaceutical Analysis ( IF 0.6 ) Pub Date : 2020-12-31 , DOI: 10.2174/1573412916666191025143214
Marilene Lopes Ângelo 1 , Fernanda de Lima Moreira 2 , Ana Laura Araújo Santos 3 , Hérida Regina Nunes Salgado 4 , Magali Benjamim de Araújo 1
Affiliation  

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 on existing methods for the analysis of 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, pharmacokinetics and pharmaceutical formulations analysis of tibolone and its metabolites.

Results and Conclusion: The major analytical method described for the analysis of tibolone in pharmaceutical formulations is High Pressure Liquid Chromatography (HPLC) coupled with 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 for the analysis of tibolone and/or its metabolites in biological fluids.



中文翻译:

替勃龙测定分析方法综述:药代动力学和药物配方分析及其在兴奋剂控制中的应用

背景:替勃龙是由Organon公司以商品名Livial(Org OD14)出售的合成类固醇,用于激素疗法,用于更年期管理和绝经后骨质疏松症的治疗。替勃龙被定义为一种选择性组织雌激素活性调节剂(STEAR),可表现出对几种器官(如脑,乳房,泌尿生殖道,子宫内膜,骨骼和心血管系统)的组织特异性作用。

目的:这项工作旨在(1)概述重要的已发表文献,概述现有的药物制剂和生物体液中替替龙和/或其代谢产物的分析方法,以及(2)对用于替勃龙及其代谢物的兴奋剂控制,药代动力学和药物制剂分析。

结果与结论:描述的用于药物制剂中替勃龙分析的主要分析方法是高压液相色谱(HPLC)结合紫外(UV)检测,而液相色谱(LC)或气相色谱(GC)与质谱联用质谱(MS)或串联质谱(MS / MS)用于分析生物液体中的替勃龙和/或其代谢产物。

更新日期:2020-11-23
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