Analysis of cisapride in neonatal plasma using high-performance liquid chromatography with a base-stable column and fluorescence detection

Preechagoon, Yupaporn; Charles, Bruce G.

doi:10.1016/0378-4347(95)00159-g

Cited by 23 publications

(12 citation statements)

References 11 publications

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“…Bepridil was measured by liquid chromatography /tandem mass spectrometry (LC / MS/ MS). Cisapride was measured by modified methods of Campanero et al (9), Park et al (10), and Preechagoon and Charles (11). Haloperidol was measured using a commercially available kit (MARKIT ® -G Haloperidol; Alfresa Pharma Corp., Osaka) and an autoanalyzer.…”

Section: Determination Of Plasma Concentrations Of Positive Compoundsmentioning

confidence: 99%

QT PRODACT: In Vivo QT Assay in the Conscious Dog for Assessing the Potential for QT Interval Prolongation by Human Pharmaceuticals

et al. 2005

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Abstract. The goal of the present study was to examine the utility of the conscious dog model by assessing the QT-interval-prolonging potential of ten positive compounds that have been reported to induce QT interval prolongation in clinical use and seven negative compounds considered not to have such an effect. Three doses of test compounds or vehicle were administered orally to male beagle dogs (n = 4), and telemetry signals were recorded for 24 h after administration. All positive compounds (astemizole, bepridil, cisapride, E-4031, haloperidol, MK-499, pimozide, quinidine, terfenadine, and thioridazine) caused a significant increase in the corrected QT (QTc) interval, with a greater than 10% increase achieved at high doses. In contrast, administration of negative compounds (amoxicillin, captopril, ciprofloxacin, diphenhydramine, nifedipine, propranolol, and verapamil) did not produce any significant change in the QTc interval, with the exception of nifedipine that may have produced an overcorrection of the QTc interval due to increased heart rate. The estimated plasma concentrations of the positive compounds that caused a 10% increase in the QTc interval were in good agreement with the plasma / serum concentrations achieved in humans who developed prolonged QT interval or torsade de pointes (TdP). Although careful consideration should be given to the interpretation of QT data with marked heart rate change, these data suggest that an in vivo QT assay using the conscious dog is a useful model for the assessment of QT interval prolongation by human pharmaceuticals. Supplementary material (Appendix): available only at http://dx

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Section: Determination Of Plasma Concentrations Of Positive Compoundsmentioning

confidence: 99%

QT PRODACT: In Vivo QT Assay in the Conscious Dog for Assessing the Potential for QT Interval Prolongation by Human Pharmaceuticals

et al. 2005

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show abstract

“…Bepridil was measured by liquid chromatography / tandem mass spectrometry (LC / MS/ MS). Cisapride was measured by modified methods of Campanero et al (11), Park et al (12), and Preechagoon and Charles (13). Haloperidol was measured using a commercially available kit (MARKIT ® -G Haloperidol; Alfresa Pharma Corp., Osaka) and an autoanalyzer.…”

Section: Determination Of Plasma Concentrations Of Test Compoundsmentioning

confidence: 99%

QT PRODACT: In Vivo QT Assay in Anesthetized Dog for Detecting the Potential for QT Interval Prolongation by Human Pharmaceuticals

et al. 2005

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Abstract. The purpose of this study was to assess the utility of the isoflurane-anesthetized dog model for detecting the potential for QT interval prolongation by human pharmaceuticals. The effects of 10 positive compounds with torsadogenic potential, 8 negative compounds with little torsadogenic potential, and dl-sotalol as a common positive compound were evaluated in 5 facilities in accordance with the common protocol approved by QT PRODACT. Each test compound was cumulatively infused into male beagle dogs anesthetized with isoflurane. Surface lead II ECG, blood pressure, and plasma concentrations for the positive compounds were measured. Repeated administration of the vehicle examined in each facility before the start of the experiments resulted in a slight, but not significant, change in corrected QT (QTc) interval, indicating that this model only shows slight experimental variation. Although an inter-facility variability in the extent of dl-sotalol-induced QT interval prolongation was observed, dl-sotalol significantly prolonged QTc interval in all facilities. All positive compounds significantly prolonged QTc interval at plasma levels up to 10 times those in patients who developed prolonged QTc interval or TdP, whereas no negative compounds did so. These data suggest that the in vivo QT assay using the anesthetized dog is a useful model for detecting the potential for QT interval prolongation by human pharmaceuticals. Supplementary material (Appendix): available only at http://dx

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“…Adjustment of this linear gradient from 90:10 to 70:30 (phosphate buffer:AcCN) over a period of 30 min led to an increase in the retention times of cisapride (RT = 22 min) and R-54680 (27 min) but ranitidine and AH20480 still eluted with the solvent front. Also the baseline from the fluorescence detector (Preechagoon and Charles have utilised fluorescence detection for its enhanced sensitivity and selectivity for cisapride determination) [19] was considerably affected by the gradient such that the sensitivity for accurate quantification at the levels required for cisapride would have been impossible.…”

Section: Discussionmentioning

confidence: 99%

“…The assay procedure for ranitidine has recently been reported by our group [15] the assay being linear (r 2 = 0.9997) over the range 8-800 ng/mL with a LOQ of 8 ng/mL and a LOD of 2 ng/mL. The determination of cisapride was carried out using the method of Prechagoon and Charles [19] that had been specifically developed for the assay of cisapride in neona- tal plasma. Fig.…”

Section: Discussionmentioning

confidence: 99%

“…Two methods have been applied to the determination of cisapride in paediatric plasma samples. Preechagoon and Charles [19] describe a HPLC method with fluorescence detection requiring the use of 100 L of plasma and Cisternino et al [20] who utilised HPLC with UV detection and 150 L of plasma. Both these methodologies have been applied to the analysis paediatric samples.…”

Section: Introductionmentioning

confidence: 99%

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Liquid chromatographic determination including simultaneous “on-cartridge” separation of ranitidine cisapride drug combinations from paediatric plasma samples using an automated solid-phase extraction procedure

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Mitchel

Millership

et al. 2004

Journal of Chromatography B

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Analysis of cisapride in neonatal plasma using high-performance liquid chromatography with a base-stable column and fluorescence detection

Cited by 23 publications

References 11 publications

QT PRODACT: In Vivo QT Assay in the Conscious Dog for Assessing the Potential for QT Interval Prolongation by Human Pharmaceuticals

QT PRODACT: In Vivo QT Assay in the Conscious Dog for Assessing the Potential for QT Interval Prolongation by Human Pharmaceuticals

QT PRODACT: In Vivo QT Assay in Anesthetized Dog for Detecting the Potential for QT Interval Prolongation by Human Pharmaceuticals

Liquid chromatographic determination including simultaneous “on-cartridge” separation of ranitidine cisapride drug combinations from paediatric plasma samples using an automated solid-phase extraction procedure

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