Rapid determination of anastrozole in plasma by gas chromatography with electron capture detection and its application to an oral pharmacokinetic study in healthy volunteers.
A rapid, sensitive and accurate capillary gas chromatographic assay with (63)Ni electron capture detection was developed for the determination of anastrozole in human plasma. It comprises a one-step liquid-liquid extraction procedure and gas chromatography on a capillary column using constant oven temperature. This method has been applied to the oral pharmacokinetic study of anastrozole in healthy Chinese male volunteers. Pharmacokinetic parameters of two anastrozole preparations were evaluated after single, oral administrations to 18 subjects at a dose of 1 mg in a single-blind cross-over trial. Plasma anastrozole concentration-time profiles were best described by a two-compartment model. After oral administrations of imported and domestic anastrozole tablets, the t(max) and C(max) were 1.52 +/- 1.04 h and 8.75 +/- 3.03 ng/mL for the former, and 1.43 +/- 1.12 h and 9.44 +/- 3.59 ng/mL for the latter; the elimination half-life was 46.0 +/- 25.2 h vs 41.2 +/- 8.8 h, and the area under the curve (AUC) was 423 +/- 114 ng h/mL vs 444 +/- 157 ng h/mL. The result indicates that the two products are bioequivalent.
Duan
Gengli
G
Department of Pharmaceutical Analysis, Pharmacy Faculty of Fudan University, Shanghai 200032, People's Republic of China. glduan@shmu.edu.cn
Liang
Jianying
J
Zuo
Ming
M
D000284:Administration, Oral; D000328:Adult; D000077384:Anastrozole; D019540:Area Under Curve; D047072:Aromatase Inhibitors; D002849:Chromatography, Gas / Q000379:methods*; D018592:Cross-Over Studies; D004791:Enzyme Inhibitors / Q000008:administration & dosage / Q000097:blood* / Q000493:pharmacokinetics; D006207:Half-Life; D006801:Humans; D008297:Male; D009570:Nitriles / Q000008:administration & dosage / Q000097:blood* / Q000493:pharmacokinetics; D012016:Reference Values; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D014230:Triazoles / Q000008:administration & dosage / Q000097:blood* / Q000493:pharmacokinetics
D047072:Aromatase Inhibitors; D004791:Enzyme Inhibitors; D009570:Nitriles; D014230:Triazoles; D000077384:Anastrozole