New method for determination of dydrogesterone in human plasma for therapeutic drug monitoring in gynecological disorders.
A new simple, sensitive and selective liquid chromatography coupled with mass spectrometry (LC/MS) method for quantification of dydrogesterone in human plasma was validated.


METHODS
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.


RESULTS
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.
Mihu
D
D
School of Medicine, "I. Haţieganu" University of Medicine and Pharmacy Cluj-Napoca.
Imre
Silvia
S
Vlase
L
L
Achim
Marcela
M
Cuciureanu
Magdalena
M
D002853:Chromatography, Liquid; D016903:Drug Monitoring / Q000379:methods*; D004394:Dydrogesterone / Q000097:blood* / Q000493:pharmacokinetics / Q000627:therapeutic use; D005260:Female; D005831:Genital Diseases, Female / Q000097:blood* / Q000188:drug therapy*; D006801:Humans; D013058:Mass Spectrometry; D011372:Progestins / Q000097:blood* / Q000493:pharmacokinetics / Q000627:therapeutic use; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
D011372:Progestins; D004394:Dydrogesterone