New method for determination of dydrogesterone in human plasma for therapeutic drug monitoring in gynecological disorders
Mihu, D.; Imre, S.; Vlase, L.; Achim, M.; Cuciureanu, M.
Revista Medico-Chirurgicala a Societatii de Medici Si Naturalisti Din Iasi 112(3): 837-842
2008
ISSN/ISBN: 0048-7848 PMID: 20201278 Document Number: 13713
A new simple, sensitive and selective liquid chromatography coupled with mass spectrometry (LC/MS) method for quantification of dydrogesterone in human plasma was validated. The analytes was eluted in 1.3 minutes on a reversed phase column (Zorbax SB-C18, 100 mm x 3.0 mm I.D., 3.5 microm) under isocratic conditions using a mobile phase of a 20 : 80 (v/v) mixture of ammonium acetate 1 mM and acetonitrile. The flow rate was 1 mL/min at the column temperature of 35 degrees C. The detection of the analyte was in MS/ MS mode using an atmospheric pressure chemical ionization source (APCI+, m/z 313 > m/z 295). The sample preparation was very simple and rapid and consisted in plasma protein precipitation from 0.2 mL plasma using 0.6 mL methanol. Calibration curves were generated over the range of 5-150 ng/mL with values for coefficient of determination greater than 0.997 and by using a weighted (1/y) linear regression. The values of precision and accuracy were less than 12.5% and 7.5%, respectively, both for within- and between-run analysis. The mean recovery of the analyte was 99.8%. This is the first reported method for analysis dydrogesterone in human plasma that uses protein precipitation as sample processing procedure. The validated LC/MS method could be applied for determination of dydrogesterone in human plasma for therapeutic drug monitoring in gynecological disorders.
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