Determination of tadalafil in small volumes of plasma by high-performance liquid chromatography with UV detection

Ching Ling Cheng, Chen-Hsi Chou

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39 Citations (Scopus)

Abstract

Tadalafil is a potent reversible phosphodiesterase-5 inhibitor used for the treatment of erectile dysfunction. This study describes a simple and sensitive high-performance liquid chromatographic (HPLC) method for the determination of tadalafil in 50 μl of rat plasma. Tadalafil and the internal standard lamotrigine were extracted with 0.5 ml of tert-butyl methyl ether, after the samples alkalinized with 20 μl of sodium hydroxide solution (1N). Chromatographic separation was achieved on a C18 column with the mobile phase of acetonitrile-water containing 20 mM phosphate buffer (pH 7) (35/65, v/v), at a flow rate of 1 ml/min. The eluant was detected at 290 nm. The retention time was about 4.5 min for lamotrigine and 15 min for tadalafil. No endogenous substances were found to interfere. Calibration curves were linear from 10 to 2000 ng/ml. The recovery of tadalafil from plasma was greater than 77%. The limit of quantitation was 10 ng/ml. The intra- and inter-day imprecision (expressed as coefficient of variation, C.V.) did not exceed 10.7%, and the accuracy was within 5.9% deviation of the nominal concentration. The method is suitable in pharmacokinetic investigation and monitoring tadalafil concentration.

Original languageEnglish
Pages (from-to)278-284
Number of pages7
JournalJournal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences
Volume822
Issue number1-2
DOIs
Publication statusPublished - 2005 Aug 5

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Plasma Volume
High performance liquid chromatography
High Pressure Liquid Chromatography
Plasmas
Phosphodiesterase 5 Inhibitors
Sodium Hydroxide
Pharmacokinetics
Erectile Dysfunction
Calibration
Tadalafil
Rats
Buffers
Phosphates
Flow rate
Recovery
Water
Monitoring
Liquids

All Science Journal Classification (ASJC) codes

  • Biochemistry

Cite this

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abstract = "Tadalafil is a potent reversible phosphodiesterase-5 inhibitor used for the treatment of erectile dysfunction. This study describes a simple and sensitive high-performance liquid chromatographic (HPLC) method for the determination of tadalafil in 50 μl of rat plasma. Tadalafil and the internal standard lamotrigine were extracted with 0.5 ml of tert-butyl methyl ether, after the samples alkalinized with 20 μl of sodium hydroxide solution (1N). Chromatographic separation was achieved on a C18 column with the mobile phase of acetonitrile-water containing 20 mM phosphate buffer (pH 7) (35/65, v/v), at a flow rate of 1 ml/min. The eluant was detected at 290 nm. The retention time was about 4.5 min for lamotrigine and 15 min for tadalafil. No endogenous substances were found to interfere. Calibration curves were linear from 10 to 2000 ng/ml. The recovery of tadalafil from plasma was greater than 77{\%}. The limit of quantitation was 10 ng/ml. The intra- and inter-day imprecision (expressed as coefficient of variation, C.V.) did not exceed 10.7{\%}, and the accuracy was within 5.9{\%} deviation of the nominal concentration. The method is suitable in pharmacokinetic investigation and monitoring tadalafil concentration.",
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