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Sensitive quantification of ranolazine in human plasma by liquid chromatography--tandem mass spectrometry with positive electrospray ionization.
J Chromatogr B Analyt Technol Biomed Life Sci. 2007 Feb 01; 846(1-2):346-50.JC

Abstract

A rapid, selective and sensitive liquid chromatography-tandem mass spectrometry (LC-MS-MS) method with positive electrospray ionization (ESI) was developed for the quantification of ranolazine in human plasma. After liquid-liquid extraction of ranolazine and internal standard (ISTD) phenoprolamine from a 100 microl specimen of plasma, HPLC separation was achieved on a Nova-Pak C(18) column, using acetonitrile-water-formic acid-10% n-butylamine (70:30:0.5:0.08, v/v/v/v) as the mobile phase. The mass spectrometer was operated in multiple reaction monitoring (MRM) mode using the transition m/z 428.5-->m/z 279.1 for ranolazine and m/z 344.3-->m/z 165.1 for the internal standard, respectively. Linear calibration curves were obtained in the concentration range of 5-4000 ng/ml, with a lower limit of quantitation (LLOQ) of 5 ng/ml. The intra- and inter-day precision values were below 3.7% and accuracy was within +/-3.2% at all three quality control (QC) levels. This method was found suitable for the analysis of plasma samples collected during the phase I pharmacokinetic studies of ranolazine performed in 28 healthy volunteers after single oral doses from 200 mg to 800 mg.

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Authors+Show Affiliations

Tian L
Clinical Pharmacology Center, Fu Wai Hospital, CAMS and PUMC, 167 Beilishi Road, Beijing 100037, PR China.
Jiang J
No affiliation info available
Huang Y
No affiliation info available
Hua L
No affiliation info available
Liu H
No affiliation info available
Li Y
No affiliation info available

MeSH

AcetanilidesAdministration, OralCalibrationChromatography, High Pressure LiquidEnzyme InhibitorsHumansPiperazinesRanolazineReference StandardsReproducibility of ResultsSensitivity and SpecificitySpectrometry, Mass, Electrospray Ionization

Pub Type(s)

Journal Article
Validation Study

Language

eng

PubMed ID

16959552

Citation

Tian, Lei, et al. "Sensitive Quantification of Ranolazine in Human Plasma By Liquid Chromatography--tandem Mass Spectrometry With Positive Electrospray Ionization." Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences, vol. 846, no. 1-2, 2007, pp. 346-50.
Tian L, Jiang J, Huang Y, et al. Sensitive quantification of ranolazine in human plasma by liquid chromatography--tandem mass spectrometry with positive electrospray ionization. J Chromatogr B Analyt Technol Biomed Life Sci. 2007;846(1-2):346-50.
Tian, L., Jiang, J., Huang, Y., Hua, L., Liu, H., & Li, Y. (2007). Sensitive quantification of ranolazine in human plasma by liquid chromatography--tandem mass spectrometry with positive electrospray ionization. Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences, 846(1-2), 346-50.
Tian L, et al. Sensitive Quantification of Ranolazine in Human Plasma By Liquid Chromatography--tandem Mass Spectrometry With Positive Electrospray Ionization. J Chromatogr B Analyt Technol Biomed Life Sci. 2007 Feb 1;846(1-2):346-50. PubMed PMID: 16959552.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Sensitive quantification of ranolazine in human plasma by liquid chromatography--tandem mass spectrometry with positive electrospray ionization. AU - Tian,Lei, AU - Jiang,Juanjuan, AU - Huang,Yiling, AU - Hua,Lu, AU - Liu,Hong, AU - Li,Yishi, Y1 - 2006/09/07/ PY - 2006/06/29/received PY - 2006/08/03/revised PY - 2006/08/07/accepted PY - 2006/9/9/pubmed PY - 2007/4/3/medline PY - 2006/9/9/entrez SP - 346 EP - 50 JF - Journal of chromatography. B, Analytical technologies in the biomedical and life sciences JO - J Chromatogr B Analyt Technol Biomed Life Sci VL - 846 IS - 1-2 N2 - A rapid, selective and sensitive liquid chromatography-tandem mass spectrometry (LC-MS-MS) method with positive electrospray ionization (ESI) was developed for the quantification of ranolazine in human plasma. After liquid-liquid extraction of ranolazine and internal standard (ISTD) phenoprolamine from a 100 microl specimen of plasma, HPLC separation was achieved on a Nova-Pak C(18) column, using acetonitrile-water-formic acid-10% n-butylamine (70:30:0.5:0.08, v/v/v/v) as the mobile phase. The mass spectrometer was operated in multiple reaction monitoring (MRM) mode using the transition m/z 428.5-->m/z 279.1 for ranolazine and m/z 344.3-->m/z 165.1 for the internal standard, respectively. Linear calibration curves were obtained in the concentration range of 5-4000 ng/ml, with a lower limit of quantitation (LLOQ) of 5 ng/ml. The intra- and inter-day precision values were below 3.7% and accuracy was within +/-3.2% at all three quality control (QC) levels. This method was found suitable for the analysis of plasma samples collected during the phase I pharmacokinetic studies of ranolazine performed in 28 healthy volunteers after single oral doses from 200 mg to 800 mg. SN - 1570-0232 UR - https://www.unboundmedicine.com/medline/citation/16959552/Sensitive_quantification_of_ranolazine_in_human_plasma_by_liquid_chromatography__tandem_mass_spectrometry_with_positive_electrospray_ionization_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1570-0232(06)00663-5 DB - PRIME DP - Unbound Medicine ER -