Solid-phase extraction and liquid chromatography/tandem mass spectrometry assay for the determination of pitavastatin in human plasma and urine for application to Phase I clinical pharmacokinetic studies
| Autor: | Li-Ping Zhao, Feng Yu, Mengxiang Su, Lei-Ping He, Lan-jin Qu, Bin Di, Ming-Chuan Cheng |
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| Rok vydání: | 2007 |
| Předmět: |
Adult
Male Formic acid Electrospray ionization Clinical Biochemistry Tandem mass spectrometry Biochemistry Sensitivity and Specificity Analytical Chemistry chemistry.chemical_compound Pharmacokinetics Liquid chromatography–mass spectrometry Tandem Mass Spectrometry medicine Humans Solid phase extraction Pitavastatin Chromatography Solid Phase Extraction Reproducibility of Results Cell Biology General Medicine Reference Standards chemistry Quinolines Female Hydroxymethylglutaryl-CoA Reductase Inhibitors Quantitative analysis (chemistry) medicine.drug |
| Zdroj: | Journal of chromatography. B, Analytical technologies in the biomedical and life sciences. 868(1-2) |
| ISSN: | 1570-0232 |
| Popis: | A sensitive liquid chromatography/tandem mass spectrometry (LC/MS/MS) method was developed and evaluated for the determination of pitavastatin in human plasma and urine. Samples were extracted using solid-phase extraction (SPE). The major benefit of the present method was the high sensitivity, with a lower limit of quantification (LLOQ) of 0.08 ng/mL. Pitavastatin and internal standard (IS, rosuvastatin) were separated on a C18 column with a mobile phase consisted of methanol/water (75:25, v/v) with 0.05% formic acid. Drug and IS were detected by LC/MS/MS with positive electrospray ionization (ESI). Accuracy and precision for the assay were determined by calculating the intra- and inter-batch variation of quality control (QC) samples at three concentration levels, with relative standard deviations (R.S.D.s) of less than 15%. The developed method was successfully applied to determine pitavastatin in human plasma and urine, and was proved to be suitable for use in Phase I clinical pharmacokinetic study after oral administration of pitavastatin (1, 2 and 4 mg) in healthy Chinese volunteers. |
| Databáze: | OpenAIRE |
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