Exemestane, (6-methylenandrostan-1,4-diene-3,17-dione) is an anti-estrogen drug used in an adjuvant treatment of advanced estrogen receptors (ER)-positive breast cancer in postmenopausal women. It is a highly specific and irreversible steroidal aromatase inhibitor, structurally related to the natural substrate androstenedione and metabolized to an intermediate that binds to the active site of the enzyme and inactivates it. It decreases estradiol concentrations, but has no effect on the synthesis of glucocorticosteroids or aldosterone.

A sensitive liquid chromatography – mass spectrometry (LC/MS/MS) method for the determination of exemestane in human plasma is designed for the application to the pharmacokinetic studies in humans, i.e. bioequivalence studies. The method will be validated according to FDA and EMEA requirements.

The development of LC/MS/MS method for the determination of exemestane in human plasma is part of the research project of Pharmaceutical Research Institute entitled „Innovative technologies of oncological medicines of special therapeutic and social importance”. The project is supported by the European Regional Development Fund (ERDF).

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