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Development and Validation of New Analytical Methods for the Determination of Drugs and Their Metabolites

A special issue of International Journal of Molecular Sciences (ISSN 1422-0067). This special issue belongs to the section "Molecular Pharmacology".

Deadline for manuscript submissions: 29 June 2025 | Viewed by 470

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Department of Inorganic Chemistry, Medical University of Lublin, Chodźki 4a, 20-093 Lublin, Poland
Interests: liquid chromatography; optimization of chromatographic systems for separation of ionic compounds; quantitative analysis of ionic compounds in biological samples
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Special Issue Information

Dear Colleagues,

In pharmaceutical and biomedical research, the analytical investigation of bulk drugs, drug formulations, impurities, degradation products, and biological samples containing drugs and their metabolites is very important. The rapid increase in pharmaceutical industries, the development of new drugs and clinical research, and the need to improve the effectiveness and safety of pharmacotherapy have led to a rising demand for novel analytical methods. Consequently, the development and validation of analytical methods are essential to achieve reliable analytical data. Various analytical techniques, such as chromatographic, spectroscopic, electrophoretic, and electrochemical methods, can be applied to analyse drugs and their metabolites.

This Special Issue on the “Development and Validation of New Analytical Methods for the Determination of Drugs and Their Metabolites” will cover a wide range of topics, including, but not limited to, the following:

  • Validated methods for the analysis of drugs and their metabolites in biological samples;
  • Pharmacokinetics;
  • Metabolism studies;
  • Detection of illicit/recreational drug use;
  • Therapeutic drug monitoring;
  • Toxicological analysis;
  • Sports doping evaluation;
  • Characterization and detection of new therapeutics;
  • Development and validation of a stability-indicating method for the estimation of drugs in bulk and pharmaceutical formulations;
  • Chromatographic analysis of natural products.

This Special Issue is supervised by Dr. Anna Petruczynik and assisted by our Topical Advisory Panel Member Dr. Karol Wróblewski (University of Rzeszów).

Dr. Anna Petruczynik
Guest Editor

Manuscript Submission Information

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Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. International Journal of Molecular Sciences is an international peer-reviewed open access semimonthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. There is an Article Processing Charge (APC) for publication in this open access journal. For details about the APC please see here. Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • drugs
  • drug formulations
  • pharmacokinetics
  • metabolism studies
  • analytical techniques

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Published Papers (1 paper)

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Research

11 pages, 1236 KiB  
Article
Determination of Dronedarone and Debutyldronedarone in Human Plasma by HPLC-UV
by Paweł K. Kunicki and Adam Stocki
Int. J. Mol. Sci. 2025, 26(9), 4304; https://doi.org/10.3390/ijms26094304 - 1 May 2025
Viewed by 175
Abstract
Dronedarone (DRO) is an antiarrhythmic drug that should be used under close supervision, and therapeutic drug monitoring (TDM) may be one of the tools supporting pharmacotherapy. The aim of our study was to develop an economical HPLC method for determining DRO and its [...] Read more.
Dronedarone (DRO) is an antiarrhythmic drug that should be used under close supervision, and therapeutic drug monitoring (TDM) may be one of the tools supporting pharmacotherapy. The aim of our study was to develop an economical HPLC method for determining DRO and its active metabolite debutyldronedarone (DBD) in human plasma. An HPLC isocratic system with a manual injector was applied. The separation was performed on a Supelcosil LC-CN column (150 × 4.6 mm, 5 µm) at an ambient temperature. The mobile phase was a mixture of CH3OH:CH3CN:H2O:0.5 M KH2PO4 (170:85:237.2:7.8 (v/v)) + 0.1 mL 85% H3PO4 pumped at a flow rate of 1.8 mL/min. The UV detection was set at λ = 290 nm. A methyl tert-butyl ether was used for the extraction from a 0.4 mL alkalized plasma sample. The analytes were eluted at retention times of 4.0 min, 5.2 min and 6.0 min for DBD, internal standard bepridil and DRO, respectively. The method was calibrated in the range of 10–1000 ng/mL for both DRO and DBD. The adequate specificity, accuracy and precision were demonstrated in accordance with EMA guidelines, i.e., ≤15% (≤20% for the LLOQ), which ensures the reliability of the measurements. This method can be recommended for laboratories with basic HPLC equipment for TDM, adherence assessments and even in PK studies during chronic DRO therapy. Full article
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