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|Type:||Artigo de periódico|
|Title:||Cyproterone Acetate Quantification in Human Plasma by High-performance Liquid Chromatography Coupled to Atmospheric Pressure Photoionization Tandem Mass Spectrometry Application to a comparative pharmacokinetics study|
da Silva, WM
|Abstract:||A specific, fast and sensitive high performance liquid chromatography (HPLC) coupled to atmospheric pressure photoionization (APPI) tandem mass spectrometric (LC-MSIMS) assay was developed for the determination of cyproterone (CYP) acetate (CAS 427-51-0) in human plasma. The retention times were 3.26 and 2.90 min for CYP acetate and its internal standard (I. S.) finasteride (FIN), respectively. The overall mean recovery, using liquid/liquid extraction, was found to be 109.0, 107.7 and 100.3%, for low, medium and high concentrations, respectively. Calibration curves were linear in the concentration range of 0.1-50.0 ng/ml, and the lower limit of quantification (LLOQ) was 0.1 ng/ml. The LLOQ, 0.1 ng/ml, was sensitive enough for detecting terminal phase concentrations of the drug. Inter-batch precision of the method ranged from 2.2 to 5.55 %, while Inter-batch accuracy ranged from 95.5 to 100.0%. Intra-batch precision ranged from 1.8 to 5.6%, while Intra-batch accuracy ranged from 92.0 to 99.4% at concentrations of 0.3 ng/ml, 20.0 and 40.0 ng/ml. The developed method was applied to a bioequivalenc study of CYP acetate in a group of 44 female volunteers at a single oral dose of a 2 mg tablet, in a combination of ethinylestradiol/CYP acetate (0.25/2 mg). The plasma concentration of CYP acetate did not differ significantly after administration of both formulations (test formulation and the reference one). The geometric mean and respective 90 % Cl of CYP acetate test/reference percent ratios were 90.66 % (84.39-97.40%) for C(max) and 96.20% (90.45-102.33%) for AUC(0-t).|
Cyproterone acetate bioequivalence, liquid chromatography, tandem mass spectrometry, pharmacokinetics
|Editor:||Ecv-editio Cantor Verlag Medizin Naturwissenschaften|
|Citation:||Arzneimittel-forschung-drug Research. Ecv-editio Cantor Verlag Medizin Naturwissenschaften, v. 59, n. 7, n. 335, n. 344, 2009.|
|Appears in Collections:||Unicamp - Artigos e Outros Documentos|
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