Development of a validated liquid chromatography method for the simultaneous determination of ethinyl estradiol, cyproterone acetate, and norgestrel in breast milk following solid-phase extraction

Journal of Liquid Chromatography and Related Technologies

Volumn 29, Issue 5, 2006, Pages 685-700

  Markopoulou, Catherine ^a   Koundourellis, John ^a  

^a ARISTOTLE UNIVERSITY OF THESSALONIKI   (Greece)

Author keywords

Breast milk; Cyproterone acetate; Ethynyl estradiol; HPLC; Norgestrel; Solid phase extraction

Indexed keywords

ALCOHOLS; EXTRACTION; SODIUM CHLORIDE; ULTRAVIOLET SPECTROSCOPY;

BREAST MILK; CYPROTERONE ACETATE; ETHYNYL ESTRADIOL; NORGESTREL; SOLID-PHASE EXTRACTION;

LIQUID CHROMATOGRAPHY;

ACETONITRILE; CYPROTERONE ACETATE; ETHINYLESTRADIOL; NORGESTREL; SULFONIC ACID DERIVATIVE;

ACCURACY; ARTICLE; BODY FLUID; BREAST MILK; CONCENTRATION (PARAMETERS); CONTROLLED STUDY; ELUTION; FEMALE; FLOW RATE; HORMONE DETERMINATION; HUMAN; LIQUID CHROMATOGRAPHY; SOLID PHASE EXTRACTION; STATISTICAL ANALYSIS; ULTRAVIOLET SPECTROSCOPY; VALIDATION STUDY;

EID: 33644648002     PISSN: 10826076     EISSN: 1520572X     Source Type: Journal    
DOI: 10.1080/10826070500509249     Document Type: Article

References (27)

1. Carmina, E.; Lobo, R. A. A comparison of the relative efficacy of antiandrogen for the treatment of acne in hyperadrogenic women. Clin. Endocrinol. 2002, 57 (2), 231-234.
2. Bye, P. Cyclic cyproterone ethinylestradiol for acne. Lancet 1983, 8347 (2), 458-458.
3. Falsetti, L.; Pasineti, E. Effects of long term administration of an oral-contraceptive containing ethinylestradiol and cyproterone-acetate on lipid metabolism in women with polycystic-ovary-syndrome. Acta Obstet. Gyn. Scan. 1995, 74 (1), 56-60.
4. Fotherby, K. 12 years of clinical-experience with an oral-contraceptive containing 30-MU-G ethinylestardiol and 150-MU-G desogestrel. Contraception 1995, 51 (1), 3-12.
5. Kuhnz, W.; Lofberg, B. Urinary-excretion of 6-Beta-hydroxycortisol in women during treatment with different oral-contraceptive formulations. J. Steroid Biochem. 1995, 55 (1), 129-133.
6. Kuhnz, W.; Staks, T.; Jutting, G. Pharmacokinetics of cyproterone-acetate and ethinylestradiol in 15 women who received a combination oral-contraceptive during 3 treatment cycles. Contraception 1993, 48 (6), 557-575.
7. Junghoffmann, C.; Kuhl, H. Pharmacokinetics and pharmacodinamics of oral contraceptive steroids-factors influencing steroid-metabolism. Am. J. Obstet. Gynecol. 1990, 163 (6), 2183-2197.
8. Christiaens, B.; Chiap, P.; Rbeida, O.; Cello, D.; Crommen, J.; Hubert, P.J. Fully automated method for the liquid chromatographic determination of cyproterone acetate in plasma using restricted access material for sample preparation. Chromatogr. B 2003, 795, 73-82.
9. Bebawy, L.I.; Mostafa, A.A.; Refaat, H.H. Different methods for the determination of gestodene, and cyproterone acetate in raw material and dosage forms. J. Pharm. Biomed. Anal. 2001, 25, 425-436.
10. Lopez de Alba, M.J.; Barcelo, D. Use of solid-phase extraction in various of its metabolities for sample preparation in the determination of estrogen ang progestrogens in sediment and water. J. Chromatogr. A. 2001, 938, 145-153.
11. Wong, F.A.; Edom, R.W.; Duda, M.; Tischio, J.P.; Huang, M.; Juzwin, S.; Tegegne, G. Determination of norgestimate and its metabolites in human serum using high-performance liquid chromatography with tandem mass spectrometric. J. Chromatogr. B 1999, 734, 247-256.
12. Benzas, J.J.; Del. Castillo, B.; Castaneda, G.; Pinilla, M.J. Micellar electrokinetic capillary chromatography as an alternative method for the determination of ethinylestradiol and levo-norgestrel. Talanta 1999, 50, 261-268.
13. Pommier, F.; Sioufi, A.; Godbillon, G. Simultaneous determination of norethisterone and six metabolites in human plasma by capillary gas chromatography with mass-selective detection. J. Chromatogr. B. 1995, 674, 155-165.
14. Ahmed, A.; Elgizawy, S.; Omar, N.M. Cyclodextrin bonded phase for liquid-chromatographic separation and analysis of some oral-contraceptives. Anal. Lett. 1991, 24, 2207-2216.
15. Koundourellis, J.E.; Kenneth, E.O.; Malliou, E.T. Isoctratic High performance liquid chromatographic method for the quantitation of cyproheptadine in human milk and plasma using solvent and solid phase extraction techniques. J. Liq. Chromatogr. and Rel. Technol. 1999, 22, 603-614.
16. Hubert, Ph.; Chiap, P.; Crommen, J.; Boulanger, B.; Chapuzet, E.; Mercier, N.; Bervoas-Martin, S.; Chevalier, P.; Grandjean, D.; Lagorce, P.; Lallier, M.; Laparra, M.; Laurentie, M.C.; Nivet, J.C. The SFSTP guide on the validation of chromatographic methods for drug bioanalysis: from the Washington conference to the laboratory. Anal. Chim. Acta. 1999, 391, 135-148.
17. Kudo, M.; Ohkubo, T.; Sugawara, K. Determination of sparfloxacine in plasma by direct injection high performance liquid chromatography with column switching. J. Liq. Chromatogr. and Rel. Technol. 1999, 22, 441-449.
18. Agasoster, T. Automated determination of oxytetracycline residues in muscle, liver, milk and egg by on-line dialysis and post column reaction detection HPLC. Food Addit. Contam. 1992, 9, 615-622.
19. Zhang, M.; Moore, G.A.; Lever, M.; Gardiner, S.J.; Kirkpatrick, C.M.J.; Begg, E.J. Rapid and simple high-performance liquid chromatographic assay for the determination of metformin in human plasma and breast milk. J. Chromatogr. B 2001, 766, 175-179.
20. Kishikawa, N.; Wada, M.; Kuroda, N.; Akiyama, S.; Nakashima, K. Determination of polycyclic aromatic hydrocarbons in milk samples by high-performance liquid chromatography with fluorescence detection. J. Chromatogr. B 2003, 789, 257-264.
21. Romeu-Nadal, M.; Morere-Pons, S.; Castellote, A.I.; Sabater, L. Comparison of two methods for the extraction of fat from human milk. Anal. Chim. Acta. 2004, 513, 457-461.
22. Shang, M.; Moore, G.A.; Gardiner, S.J.; Begg, E.J. Determination of rofecoxib in human plasma and breast milk by high-performance liquid chromatographic assay. J. Chromatogr. B 2004, 807, 217-221.
23. Zimmerli, B.; Dick, R. Determination of ochratoxine A at the ppt level, in human blood, serum, milk and some oodstuffs by high-performance liquid chromatography with enhanced fluorescence detection and immunoaffinity column clean up. J. Chromatogr. 1995, 666, 85-99.
24. Rossi, D.T.; Wright, D.S. Analytical considerations for trace determination of drugs in breast milk. J. Pharm. Biomed. Anal. 1997, 15, 495-504.
25. Abbara, Ch.; Aymard, G.; Hinh, S.; Diquet, B. Simultaneous determination of quinapril and its active metabolite quinaprilat in human plasma using high-performance liquid chromatography with ultraviolet detection. J. Chromatogr. B. 2002, 766, 199-207.
26. Shah, V.P.; Midha, K.K.; Dighe, S.; McGilveray, I.J.; Skelly, J.P.; Yacobi, A.; Layloff, T.; Viswanathan, C.T.; Cook, C.E.; McDowall, R.D.; Pitman, K.A.; Spector, S. Analytical methods validation: Bioavailability, bioequivalence and pharmacokinetic studies. J. Pharm. Sci. 1992, 81, 309-321.
27. Guidance for industry: Bioanalytical Method Validation, US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), May 2001.