Special Issue "Chromatographic Methods in Therapeutic Drug Monitoring (TDM)"

A special issue of Separations (ISSN 2297-8739).

Deadline for manuscript submissions: closed (20 January 2022) | Viewed by 2822

Special Issue Editors

Dr. Giacomo Luci
E-Mail Website
Guest Editor
Department of Clinical and Experimental Medicine, University of Pisa, 56126 Pisa PI, Italy
Interests: HPLC-UV; HPLC-FLD; Chromatography; Analytical Chemistry; Analytical method validation; LC-MS/MS; Mass Spectrometry
Prof. Dr. Antonello Di Paolo
E-Mail Website
Guest Editor
Department of Clinical and Experimental Medicine, University of Pisa, 56126 Pisa PI, Italy
Interests: clinical pharmacokinetics; chemotherapeutic agents; therapeutic drug monitoring
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Special Issue Information

Dear Colleagues,

In the last years, chromatographic methods in Therapeutic Drug Monitoring (TDM) have undergone a rapid evolution, thanks to innovative and performing analytical instruments. Their characteristics consist in the increase of analytical performance in terms of the limits of determination and quantitation, lower sample quantity for analysis, extraction methods, interpretation of the analytical data and shorter time to the final report.

These innovative features have allowed TDM to be increasingly applied and broadly used, gaining significant advantages with respect to the choice of the more appropriate therapeutic dose, the capability of monitoring patients' adherence, and its applications in pharmacokinetic studies. Respecting these parameters is fundamental for therapy effectiveness, tolerability, and safety, which characterize the complex management of patients for whom TDM plays a fundamental role.

In agreement with the aims of Separations journal, the focus of this Special Issue is to emphasize all innovative analytical methods in TDM that can bring advantages in terms of the turn around time, the cost and the difficulty of analysis, the robustness, reproducibility, specificity, and sensitivity of the analytical method.

The scope of this Special Issue will serve as a forum for manuscripts on the following topics:

  • Solid Phase Extraction methods applied to chromatographic methods
  • Rapid extraction phase
  • New and innovative extraction methods
  • Liquid chromatography methods
  • Mass spectrometric methods
  • Innovative methods and advantages respect to other analytical procedure
  • Validation in according to international guidelines
  • Possible clinical advantage from TDM

Dr. Giacomo Luci
Prof. Dr. Antonello Di Paolo
Guest Editors

Manuscript Submission Information

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Keywords

  • Therapeutic Drug Monitoring (TDM)
  • LC-MS/MS
  • Chromatographic Method
  • HPLC-UV or FLD
  • Drugs
  • Monoclonal Antibody
  • Extraction from bioloigcal matrices

Published Papers (3 papers)

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Research

Article
Validation and Clinical Application of a New Liquid Chromatography Coupled to Mass Spectrometry (HPLC-MS) Method for Dalbavancin Quantification in Human Plasma
Separations 2021, 8(10), 189; https://doi.org/10.3390/separations8100189 - 15 Oct 2021
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Abstract
Dalbavancin (DBV) is an intravenous long-acting second-generation glycolipopeptide antibiotic with high efficacy and excellent tolerability, approved for use in the treatment of Gram-positive skin and skin structure infections (ABSSSI). Nevertheless, little is known about its pharmacokinetic/pharmacodynamic (PK/PD) properties in real life, which is [...] Read more.
Dalbavancin (DBV) is an intravenous long-acting second-generation glycolipopeptide antibiotic with high efficacy and excellent tolerability, approved for use in the treatment of Gram-positive skin and skin structure infections (ABSSSI). Nevertheless, little is known about its pharmacokinetic/pharmacodynamic (PK/PD) properties in real life, which is also due to technical challenges in its quantification in human plasma, preventing an effective application of therapeutic drug monitoring (TDM). In fact, DBV has a high affinity to plasma proteins, possibly resulting in poor recovery after extraction procedure. The aim of this study was to validate a simple, cheap and reliable HPLC-MS method for use in TDM, in accordance with FDA and EMA guidelines. The optimized protein precipitation protocol required 50 μL of plasma, while chromatographic analysis could be performed in 12 min/sample. This method fulfilled the guidelines requirements and then, it was applied for routine DBV TDM in patients receiving off-label high doses (two 1500 + 1500 mg weekly infusions instead of 1000 + 500 mg), with normal renal function or undergoing hemodialysis: continuous hemodiafiltration caused a relevant reduction in DBV exposure, while intermittent dialysis showed comparable DBV concentrations with those of patients with normal renal function. This confirmed the eligibility of the presented method for use in TDM and its usefulness in clinical practice. Full article
(This article belongs to the Special Issue Chromatographic Methods in Therapeutic Drug Monitoring (TDM))
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Article
Effects of Ethanol on the Supercritical Carbon Dioxide Extraction of Cannabinoids from Near Equimolar (THC and CBD Balanced) Cannabis Flower
Separations 2021, 8(9), 154; https://doi.org/10.3390/separations8090154 - 15 Sep 2021
Cited by 1 | Viewed by 870
Abstract
In this study, supercritical carbon dioxide (scCO2) extractions of cannabinoids were conducted at four different densities (231, 590, 818, and 911 kg/m3) using ethanol (5% w/v) as a co-solvent. The chemical profiles of these cannabinoids were analysed via [...] Read more.
In this study, supercritical carbon dioxide (scCO2) extractions of cannabinoids were conducted at four different densities (231, 590, 818, and 911 kg/m3) using ethanol (5% w/v) as a co-solvent. The chemical profiles of these cannabinoids were analysed via reverse-phase high-performance liquid chromatography (RP-HPLC). It was determined that scCO2, at low density (231 kg/m3), produced an extract yield of 6.1% w/v. At high scCO2 density (~818 kg/m3), the yield was 16.1% w/v. More specifically, the amounts of tetrahydrocannabinol (THC) and cannabidiol (CBD) in the scCO2 extract at 818 kg/m3 were 10.8 and 15.6% w/v, respectively. It was also found that the use of 5% w/v ethanol increased scCO2 extract yields at both low and high densities (7.6% w/v and 18.2% w/v, respectively). Additionally, the use of co-solvent increased this yield further under both low- and high-density conditions, to 13.7 and 19.1% w/v, respectively. Interestingly, higher scCO2 density (911 kg/m3) with and without ethanol did not improve the scCO2 extract yield or the amount of cannabinoids. Although this study provides new insights into the correlation between scCO2 density and ethanol co-extraction of CBD and THC, more studies are needed to determine how different scCO2 densities and co-solvents influence the extraction of cannabinoids. Full article
(This article belongs to the Special Issue Chromatographic Methods in Therapeutic Drug Monitoring (TDM))
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Article
Determination of Mitotane (DDD) and Principal Metabolite by a Simple HPLC-UV Method and Its Validation in Human Plasma Samples
Separations 2021, 8(5), 63; https://doi.org/10.3390/separations8050063 - 09 May 2021
Cited by 1 | Viewed by 944
Abstract
Mitotane (DDD) is prescribed in adrenocortical renal carcinoma. Its principal metabolite, dichlorodiphenylethene (DDE), can accumulate in fat tissues and from a toxicological point of view, is probably more interesting than the other metabolite dichlorodiphenylacetate (DDA). Therapeutic Drug Monitoring (TDM) of DDD plasma concentrations [...] Read more.
Mitotane (DDD) is prescribed in adrenocortical renal carcinoma. Its principal metabolite, dichlorodiphenylethene (DDE), can accumulate in fat tissues and from a toxicological point of view, is probably more interesting than the other metabolite dichlorodiphenylacetate (DDA). Therapeutic Drug Monitoring (TDM) of DDD plasma concentrations is required to combine therapeutic efficacy with acceptable toxicity. Therefore, we developed a simple and fast HPLC-UV method to monitor plasma concentrations after a liquid–liquid extraction of plasma calibration samples, quality controls, and anonymous plasma samples with unknown DDD and DDE concentrations. Samples were injected into an HPLC instrument and peaks of mitotane (DDD), DDE and aldrin (internal standard, IS) were resolved by a stationary phase C18 column (250 mm × 4.6 mm, 5 μm), maintained at 35 °C. Mobile phase, made by water/acetonitrile (10/90, v/v), was pumped at a flow of 1.0 mL/min, and absorbance was monitored at a wavelength of 226 nm. Average recovery was 95% for all analytes, and the method was linear for both DDD (r2 = 0.9988, range 1–50 mg/L) and DDE (r2 = 0.9964, range 1–40 mg/L). The values of limit of detection and quantitation were 0.102 and 0.310 mg/L for DDD and 0.036 and 0.108 mg/L for DDE, respectively. The retention time values of DDD, DDE and IS were 7.06, 9.42 and 12.60 min, respectively. The method was successfully validated according to FDA guidelines and finally adopted for routine TDM. Full article
(This article belongs to the Special Issue Chromatographic Methods in Therapeutic Drug Monitoring (TDM))
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