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摘要
An accurate and selective high-performance liquid chromatography with ultraviolet detector (HPLC-UV) method was developed for quantification of alibendol in human plasma. The sample was prepared by one-step liquid-liquid extraction (LLE) using ethyl acetate from plasma. The chromatographic retention times of alibendol and carvedilol (the internal standard; IS) were 4.3 and 3.5 min, respectively, on a reverse phase C-18 CAPCELL PAK (250 mm x 4.6 mm I.D., 5 mu m) column. The isocratic mobile phase consisted of acetonitrile-10 mM sodium phosphate (45: 55, v/v; adjusted to pH 3.0 with phosphoric acid). The lower limit of quantitation (LLOQ) was 0.3 mu g/mL and no interferences were detected in chromatograms. The developed HPLC method was validated by evaluating its inter- and intra-day precisions and accuracies for a linear concentration range of 0.3 and 20.0 mu g/mL. Stability testing showed that alibendol was stable in human plasma during sample processing and storage. The proposed method was successfully applied to the pharmacokinetic study of the single-dose oral administration of 100 mg alibendol tablet in healthy Korean male volunteers. The C-max, T-1/2 and AUC(0-t) of alibendol were 5.82 +/- 1.40 mu g/mL, 1.47 +/- 0.43 h, 10.62 +/- 2.40 mu g.h/mL, respectively.
- 出版日期2016
