Simultaneous determination of metoprolol succinate and amlodipine besylate in human plasma by liquid chromatography–tandem mass spectrometry method and its application in bioequivalence study

A simple, sensitive and specific liquid chromatography–tandem mass spectrometry method was developed and validated for quantification of metoprolol succinate (MPS) and amlodipine besylate (AM) using hydrochlorothiazide (HCTZ) as IS in human plasma. Both the drugs were extracted by simple liquid–liqu...

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Veröffentlicht in:Journal of chromatography. B, Analytical technologies in the biomedical and life sciences Analytical technologies in the biomedical and life sciences, 2008-09, Vol.873 (1), p.77-85
Hauptverfasser: Sarkar, Amlan Kanti, Ghosh, Debotri, Das, Ayan, Selvan, P. Senthamil, Gowda, K. Veeran, Mandal, Uttam, Bose, Anirbandeep, Agarwal, Sangeeta, Bhaumik, Uttam, Pal, Tapan Kumar
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container_title Journal of chromatography. B, Analytical technologies in the biomedical and life sciences
container_volume 873
creator Sarkar, Amlan Kanti
Ghosh, Debotri
Das, Ayan
Selvan, P. Senthamil
Gowda, K. Veeran
Mandal, Uttam
Bose, Anirbandeep
Agarwal, Sangeeta
Bhaumik, Uttam
Pal, Tapan Kumar
description A simple, sensitive and specific liquid chromatography–tandem mass spectrometry method was developed and validated for quantification of metoprolol succinate (MPS) and amlodipine besylate (AM) using hydrochlorothiazide (HCTZ) as IS in human plasma. Both the drugs were extracted by simple liquid–liquid extraction with chloroform. The chromatographic separation was performed on a reversed-phase peerless basic C18 column with a mobile phase of methanol–water containing 0.5% formic acid (8:2, v/v). The protonated analyte was quantitated in positive ionization by multiple reaction monitoring with a mass spectrometer. The method was validated over the concentration range of 1–100 ng/ml for MPS and 1–15 ng/ml AM in human plasma. The MRM transition of m/ z 268.10–103.10, m/ z 409.10–334.20 and m/ z 296.00–205.10 were used to measure MPS, AM and HCTZ (IS), respectively. This method was successfully applied to the pharmacokinetic study of fixed dose combination (FDC) of MPS and AM formulation product after an oral administration to Indian healthy human volunteers.
doi_str_mv 10.1016/j.jchromb.2008.07.040
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subjects Amlodipine - blood
Amlodipine - pharmacokinetics
Amlodipine besylate
Analysis
Analytical, structural and metabolic biochemistry
Biological and medical sciences
Chromatography, Liquid - methods
Drug Stability
Fundamental and applied biological sciences. Psychology
General pharmacology
Hydrochlorothiazide
LC–MS/MS
Medical sciences
Metoprolol - analogs & derivatives
Metoprolol - blood
Metoprolol - pharmacokinetics
Metoprolol succinate
Pharmacology. Drug treatments
Reproducibility of Results
Sensitivity and Specificity
Tandem Mass Spectrometry - methods
Therapeutic Equivalency
Uncertainty
Validation
title Simultaneous determination of metoprolol succinate and amlodipine besylate in human plasma by liquid chromatography–tandem mass spectrometry method and its application in bioequivalence study
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