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Highly sensitive and rapid ultra-performance liquid chromatography-tandem mass spectrometry method for the determination of nifedipine in human plasma and its application to a bioequivalence study.
Biomed Chromatogr. 2012 Dec; 26(12):1509-18.BC

Abstract

An ultra performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) method has been developed for the determination of nifedipine in human plasma using nifedipine-d6 as the internal standard (IS). The plasma samples were prepared by solid-phase extraction on Phenomenex Strata-X cartridges employing 200 μL human plasma. Chromatography was carried out on Waters Acquity UPLC BEH C₁₈ (50 × 2.1 mm, 1.7 µm particle size) analytical column under isocratic conditions using a mobile phase consisting of 4.0 mm ammonium acetate-acetonitrile (15:85, v/v). The precursor → product ion transitions for nifedipine (m/z 347.2 → 315.2) and IS (m/z 353.1 → 318.1) were monitored on a triple quadrupole mass spectrometer, operating in the multiple reaction monitoring and positive-ion mode. The method was validated over a wide dynamic concentration range of 0.050-150 ng/mL. Matrix effect was assessed by post-column analyte infusion and the mean extraction recovery was 95.6% across four quality control levels. The method is rugged and rapid with a total run time of 1.2 min and was applied to a bioequivalence study of 20 mg nifedipine tablet formulation in 30 healthy Indian subjects under fasting condition. Assay reproducibility was confirmed by reanalysis of 116 incurred samples.

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Publisher Full Text (DOI)

Authors+Show Affiliations

Patel DP
Department of Chemistry, School of Sciences, Gujarat University, Navrangpura, Ahmedabad 380009, Gujarat, India.
Sharma P
No affiliation info available
Sanyal M
No affiliation info available
Singhal P
No affiliation info available
Shrivastav PS
No affiliation info available

MeSH

AdultArea Under CurveChromatography, High Pressure LiquidDrug StabilityHigh-Throughput Screening AssaysHumansMaleNifedipineReproducibility of ResultsSensitivity and SpecificitySolid Phase ExtractionTandem Mass SpectrometryTherapeutic Equivalency

Pub Type(s)

Journal Article

Language

eng

PubMed ID

22383257

Citation

Patel, Daxesh P., et al. "Highly Sensitive and Rapid Ultra-performance Liquid Chromatography-tandem Mass Spectrometry Method for the Determination of Nifedipine in Human Plasma and Its Application to a Bioequivalence Study." Biomedical Chromatography : BMC, vol. 26, no. 12, 2012, pp. 1509-18.
Patel DP, Sharma P, Sanyal M, et al. Highly sensitive and rapid ultra-performance liquid chromatography-tandem mass spectrometry method for the determination of nifedipine in human plasma and its application to a bioequivalence study. Biomed Chromatogr. 2012;26(12):1509-18.
Patel, D. P., Sharma, P., Sanyal, M., Singhal, P., & Shrivastav, P. S. (2012). Highly sensitive and rapid ultra-performance liquid chromatography-tandem mass spectrometry method for the determination of nifedipine in human plasma and its application to a bioequivalence study. Biomedical Chromatography : BMC, 26(12), 1509-18. https://doi.org/10.1002/bmc.2725
Patel DP, et al. Highly Sensitive and Rapid Ultra-performance Liquid Chromatography-tandem Mass Spectrometry Method for the Determination of Nifedipine in Human Plasma and Its Application to a Bioequivalence Study. Biomed Chromatogr. 2012;26(12):1509-18. PubMed PMID: 22383257.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Highly sensitive and rapid ultra-performance liquid chromatography-tandem mass spectrometry method for the determination of nifedipine in human plasma and its application to a bioequivalence study. AU - Patel,Daxesh P, AU - Sharma,Primal, AU - Sanyal,Mallika, AU - Singhal,Puran, AU - Shrivastav,Pranav S, Y1 - 2012/03/01/ PY - 2011/12/27/received PY - 2012/01/30/accepted PY - 2012/3/3/entrez PY - 2012/3/3/pubmed PY - 2013/2/27/medline SP - 1509 EP - 18 JF - Biomedical chromatography : BMC JO - Biomed Chromatogr VL - 26 IS - 12 N2 - An ultra performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) method has been developed for the determination of nifedipine in human plasma using nifedipine-d6 as the internal standard (IS). The plasma samples were prepared by solid-phase extraction on Phenomenex Strata-X cartridges employing 200 μL human plasma. Chromatography was carried out on Waters Acquity UPLC BEH C₁₈ (50 × 2.1 mm, 1.7 µm particle size) analytical column under isocratic conditions using a mobile phase consisting of 4.0 mm ammonium acetate-acetonitrile (15:85, v/v). The precursor → product ion transitions for nifedipine (m/z 347.2 → 315.2) and IS (m/z 353.1 → 318.1) were monitored on a triple quadrupole mass spectrometer, operating in the multiple reaction monitoring and positive-ion mode. The method was validated over a wide dynamic concentration range of 0.050-150 ng/mL. Matrix effect was assessed by post-column analyte infusion and the mean extraction recovery was 95.6% across four quality control levels. The method is rugged and rapid with a total run time of 1.2 min and was applied to a bioequivalence study of 20 mg nifedipine tablet formulation in 30 healthy Indian subjects under fasting condition. Assay reproducibility was confirmed by reanalysis of 116 incurred samples. SN - 1099-0801 UR - https://www.unboundmedicine.com/medline/citation/22383257/Highly_sensitive_and_rapid_ultra_performance_liquid_chromatography_tandem_mass_spectrometry_method_for_the_determination_of_nifedipine_in_human_plasma_and_its_application_to_a_bioequivalence_study_ L2 - https://doi.org/10.1002/bmc.2725 DB - PRIME DP - Unbound Medicine ER -

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