Simultaneous determination of triprolidine and pseudoephedrine in human plasma by liquid chromatography–ion trap mass spectrometry

A highly efficient, selective and specific method for simultaneous quantitation of triprolidine and pseudoephedrine in human plasma by liquid chromatography–ion trap-tandem mass spectrometry coupled with electro spray ionization (LC–ESI-ion trap-tandem MS) has been validated and successfully applied...

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Bibliographic Details
Published in:	Journal of chromatography. B, Analytical technologies in the biomedical and life sciences Vol. 877; no. 32; pp. 4071 - 4078
Main Authors:	Shakya, Ashok K., Arafat, Tawfiq A., Abuawwad, Ahmad N., Melhim, Munther, Al-Ghani, Jafar, Yacoub, Mahmoud J.
Format:	Journal Article
Language:	English
Published:	Amsterdam Elsevier B.V 15-12-2009 Elsevier
Subjects:	Adolescent Adult Analysis Analytical, structural and metabolic biochemistry Bioequivalence study Biological and medical sciences Chromatography, Liquid - methods Clinical Drug Combinations Fundamental and applied biological sciences. Psychology General pharmacology Histamine H1 Antagonists - blood Humans LC–MS Male Medical sciences Nasal Decongestants - blood Pharmacology. Drug treatments Pseudoephedrine Pseudoephedrine - blood Sensitivity and Specificity Tandem Mass Spectrometry - methods Triprolidine Triprolidine - blood Validation Young Adult Validation Clinical Bioequivalence study Pseudoephedrine Triprolidine LC–MS Biological fluid Agonist Chemical analysis Bioequivalence HPLC chromatography Antihistaminic Blood plasma Alkaloid Ion trap Vasoconstrictor agent Antagonist Human Sympathomimetic LC-MS α-Adrenergic receptor Simultaneous measurement Nasal decongestant α-Adrenergic receptor agonist H1 Histamine receptor Pharmacokinetics Mass spectrometry
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Summary:	A highly efficient, selective and specific method for simultaneous quantitation of triprolidine and pseudoephedrine in human plasma by liquid chromatography–ion trap-tandem mass spectrometry coupled with electro spray ionization (LC–ESI-ion trap-tandem MS) has been validated and successfully applied to a clinical pharmacokinetic study. Both targeted compounds together with the internal standard (gabapentin) were extracted from the plasma by direct protein precipitation. Chromatographic separation was achieved on a C 18 ACE ® column (50.0 mm × 2.1 mm, 5 μm, Advance Chromatography Technologies, Aberdeen, UK), using an isocratic mobile phase, consisting of water, methanol and formic acid (55:45:0.5, v/v/v), at a flow-rate of 0.3 mL/min. The transition monitored (positive mode) was m/z 279.1 → m/z 208.1 for triprolidine, m/z 165.9 → m/z 148.0 for pseudoephedrine and m/z 172.0 → m/z 154.0 for gabapentin (IS). This method had a chromatographic run time of 5.0 min and a linear calibration curves ranged from 0.2 to 20.0 ng/mL for triprolidine and 5.0–500.0 ng/mL for pseudoephedrine. The within- and between-batch accuracy and precision (expressed as coefficient of variation, %C.V.) evaluated at four quality control levels were within 94.3–106.3% and 1.0–9.6% respectively. The mean recoveries of triprolidine, pseudoephedrine and gabapentin were 93.6, 76.3 and 82.0% respectively. Stability of triprolidine and pseudoephedrine was assessed under different storage conditions. The validated method was successfully employed for the bioequivalence study of triprolidine and pseudoephedrine formulation in twenty six volunteers under fasting conditions.
Bibliography:	ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Feature-1 content type line 23 ObjectType-Article-1 ObjectType-Feature-2
ISSN:	1570-0232 1873-376X
DOI:	10.1016/j.jchromb.2009.10.021