Genistein is used for treatment of the menopause symptoms and reduces risks of heart disease, osteoporosis and some cancers. Its potential activity against psoriasis is under investigation. Genistein is present in the body as unconjugated form (free genistein) and conjugated with glucuronide and sulfate. The aim of the study was to develop and validate a bioanalytical method to determine free and total genistein in plasma, i.e. sum of free genistein and hydrolyzed metabolites.

Application of LC-MS/MS technique enabled method’s sensitivity of 250 pg/ml and 20 ng/ml for free and total genistein, respectively. Enzymatic hydrolysis, applied during sample preparation, was highly optimized. The first complementary method for the determination of free and total genistein was developed and validated in compliance with European and U.S. regulatory guidelines [1,2].

The developed method enables rapid and reliable determination of free and total genistein in plasma and was successfully applied in the pilot bioavailability study in humans.

Genistein was synthesized in the Pilot Plant Department and certified in the Quality Control Department of the Pharmaceutical Research Institute. The presented study was supported by the National Centre for Research and Development under the Programme of Applied Research, contract No. PBS1/B7/7/2012.

References:

[1]    Guideline on bioanalytical method validation. European Medicines Agency (EMEA/CHMP/EWP/192217/2009). London, 21 July 2011.

[2]    Guidance for Industry. Bioanalytical Method Validation. U.S. Department of Health and Human Services. Food and Drug Administration. Center for Drug Evaluation and Research (CDER). Center for Veterinary Medicine (CVM). May 2001.

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