• YAKHAK HOEJI
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• v.54 no.4
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• pp.295-299
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• 2010

The aim of this study was to develop and validate for determination of alibendol in human plasma by HPLC method. After precipitation of 500 ${\mu}l$ plasma samples by 50% methanol 50 ${\mu}l$ and 60% perchloric acid 30 ${\mu}l$ and the supernatant 50 ${\mu}l$ was injected into HPLC. The assay was performed isocratically using 10 mM potassium phosphate (pH 3.0) and acetonitrile (80 : 20, v/v) as mobile phase. The $C_{18}$ column (particle size $3.5{\mu}m$, $4.6{\times}50$ mm, Zorbax Eclipse) was used as a solid phase. The mobile phase was delivered at a flow-rate of 1.7 ml/min, detection was by ultraviolet absorption at 232 nm and concentrations were calculated on the basis of peak areas. In these conditions, alibendol can be separated from ethylparaben, the internal standard, and endogenous substances. The retention times of alibendol and ethylparaben were just about 2.6 and 3.5 minutes, respectively. This rapid HPLC method was validated by examining the precision and accuracy for inter- and intra-day analysis. The standard curve was linear ($R^2$=1.0000) over the concentration range of 0.05~20 ${\mu}g$/ml. The inter-day relative standard deviation (R.S.D.) and accuracy were 0.2~12.2% and 94.4~101.2% (82.7% at the lower limit of quatitation). The intra-day R.S.D. and accuracy were 0.1~11.8% and 98.8~102.5%, respectively. The method was successfully applied to the determination of alibendol in plasma for a pharmacokinetic study.

• Bulletin of the Korean Chemical Society
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• v.25 no.11
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• pp.1720-1722
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• 2004

• YAKHAK HOEJI
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• v.54 no.5
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• pp.348-353
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• 2010

The dissolution test method and an analytical procedure by HPLC were developed and validated for viquidil hydrochloride capsules and alibendol tablets. These drugs were not yet characterized by the dissolution specifications in Korean Pharmaceutical Codex. So, with each reference and test drugs, we did the preliminary and standard experiments based on the Korean Pharmacopeia Guideline of dissolution testing for solid oral dosage forms. The dissolution test for viquidil hydrochloride capsules was carried out under sink conditions as follows: dissolution medium water, paddle rotation speed 50 rpm and vessel volume 900 ml. More than 90% of its label amount was released within 30 min in this method. Also the dissolution test for alibendol tablets was carried out under sink conditions as follows: dissolution medium water, paddle rotation speed 100 rpm and vessel volume 900 ml. More than 90% of its label amount was released within 45 min in this method. The dissolution samples were analyzed with a precise and accurate HPLC method. The developed dissolution test showed specificity, linearity, precision and accuracy within the acceptable range. The dissolution testing method described above was adequate for the purpose and may be proposed as a pharmacopeial standard to assess the performance of viquidil hydrochloride capsules and alibendol tablets.

• Proceedings of the Korean Society of Life Science Conference
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• 2002.09a
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• pp.59-59
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• 2002