DEVELOPMENT AND VALIDATION OF A LC-MS /MS METHOD FOR THE QUANTITATIVE DETERMINATION OF TRAMADOL HYDROCHLORIDE

Authors

  • Alina Diana PANAINTE “Grigore T. Popa” University of Medicine and Pharmacy Iasi
  • Viorica POPA “Grigore T. Popa” University of Medicine and Pharmacy Iasi
  • Luminita AGOROAEI “Grigore T. Popa” University of Medicine and Pharmacy Iasi
  • Carmen Diana CIMPOESU “Grigore T. Popa” University of Medicine and Pharmacy Iasi
  • A. SAVA “Grigore T. Popa” University of Medicine and Pharmacy Iasi
  • Larisa PADURARU “Grigore T. Popa” University of Medicine and Pharmacy Iasi
  • Nela BIBIRE “Grigore T. Popa” University of Medicine and Pharmacy Iasi

Abstract

The aim of this study was to develop and validated a highly sensitive, accurate, and precise liquid chromatography and tandem mass spectrometry (LC/MS/MS) method for quantitative analysis of tramadol (TMH) in human plasma using metoprolol tartrate as internal standard (IS). Material and methods: Quantitative analysis was done with methanol and 0.15 % formic acid in water (40:60, v/v) as the mobile phase and C18 as the stationary phase with a flow rate of 0.5 mL/min and MS as the detector. The mass spectrometer was operated in positive polarity mode. The method was validated for specificity, sensitivity, precision, accuracy, and other analytical parameters. The level of tramadol data was statistically analyzed using ANOVA at a 95% confidence level. Results: The total analytical run time was 2.5 min. The results found were satisfactory over the linear calibration range of 10-500 ng/mL for TMH. It is a simple, fast, precise and accurate liquid chromatographic method. Conclusions: The developed method can be used by scientific community for the quantification of tramadol in plasma samples from various clinical studies of different dose strengths.

Author Biographies

  • Alina Diana PANAINTE, “Grigore T. Popa” University of Medicine and Pharmacy Iasi

    Faculty of Pharmacy,
    Department of Analytical Chemistry

  • Viorica POPA, “Grigore T. Popa” University of Medicine and Pharmacy Iasi

    Faculty of Medicine,
    Department of Surgery (II)

  • Luminita AGOROAEI, “Grigore T. Popa” University of Medicine and Pharmacy Iasi

    Faculty of Pharmacy,
    Department of Toxicology

  • Carmen Diana CIMPOESU, “Grigore T. Popa” University of Medicine and Pharmacy Iasi

    Faculty of Medicine,
    Department of Surgery (II)

  • A. SAVA, “Grigore T. Popa” University of Medicine and Pharmacy Iasi

    Faculty of Pharmacy,
    Department of Analytical Chemistry

  • Larisa PADURARU, “Grigore T. Popa” University of Medicine and Pharmacy Iasi

    Faculty of Pharmacy,
    Department of Analytical Chemistry

  • Nela BIBIRE, “Grigore T. Popa” University of Medicine and Pharmacy Iasi

    Faculty of Pharmacy,
    Department of Analytical Chemistry

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Additional Files

Published

2023-03-31

Issue

Vol. 127 No. 1 (2023): The Medical-Surgical Journal

Section

PHARMACY

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